LUNG COMMITTEE

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					                        LUNG COMMITTEE

                      Chair: David R. Gandara, M.D.
                Vice Chairs: Wilbur A. Franklin, M.D. (Pathology)
                             Laurie E. Gaspar, M.D. (Radiation Onc)
                             Paul H. Gumerlock, Ph.D. (Molecular Biol)
                             Roy Herbst, M.D., Ph.D. (Develop Ther)
                             Paul J. Hesketh, M.D. (Community Affil)
                             Karen Kelly, M.D. (Medical Oncology)
                             Eric Vallieres, M.D. (Thoracic Surgery)

         Statisticians: John J. Crowley, Ph.D.
                        Kari Chansky, M.S.
                        Jason McCoy, M.S.
  Data Coordinators: Vicki Green, M.R.T.
                        Camille White, B.S., C.C.R.P.
                        Larry Kaye, B.A.
                        Janice Leaman
Protocol Coordinator: Connie Ballon-Almanza, B.S.
      Cancer Control Gary E. Goodman, M.D.
              Liaison:
               Nurses: Deborah S. Ward, N.P.
                        Ruth A. Chaplen, R.N., M.S.N.

      Clinical Research George Bennig, C.C.R.P.
             Associate:



APRIL 7 - 10, 2005            SOUTHWEST ONCOLOGY GROUP          LUNG   1
                                            CONTENTS
           Lung Committee Agenda. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

           Initial Registrations to Therapeutic Studies . . . . . . . . . . . . . . . . . . . . . 5

           Patient Registration by Study and Arm . . . . . . . . . . . . . . . . . . . . . . . 6

           S9900 Phase III Intergroup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

           S9925 Biologic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

           S0023 Phase III Intergroup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

           S0027 Phase II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

           S0119 Phase II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

           S0124 Phase III. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

           S0126 Phase II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

           S0220 Phase II Intergroup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

           S0222 Phase II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

           S0229 Ancillary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

           S0310 Phase II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

           S0327 Phase II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

           S0339 Phase II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

           S0341 Phase II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

           S0342 Phase II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

           S0424 Epidemiologic Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

           S0429 Phase I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

           S0435 Phase II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

           S0436 Phase II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

           S0509 Phase II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

           S0510 Phase II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

           C30102 Phase III SWOG Endorsed CTSU Study . . . . . . . . . . . . . . . . . 73

           E5597 Phase III Intergroup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

           JBR19 Phase III SWOG Endorsed CTSU Study. . . . . . . . . . . . . . . . . . 77

           R0212 Phase II-III Intergroup (RTOG-0212) . . . . . . . . . . . . . . . . . . . 79

           R0214 Phase III SWOG Endorsed CTSU Study. . . . . . . . . . . . . . . . . . 81



2   LUNG                              SOUTHWEST ONCOLOGY GROUP                                        APRIL 7 - 10, 2005
                                            Lung Committee Agenda

                                                  Scientific Session
                     Targeted Therapy for NSCLC 2005- A Progress Report           Roy Herbst, M.D., Ph.D.
                                                                                  MD Anderson Cancer
                                                                                  Center
                     ZD6474 and AZD2171: Two Novel Inhibitors of VEGF Receptor    Peter Langmuir, M.D.
                     Signaling                                                    AstraZeneca
                                                                                  Pharmaceuticals

                                                   Closed Studies
   S9712             NSCL, Poor Risk Stage III.                                   Dr. Lau

   S9714             Bronchioloalveolar.                                          Dr. West

   S9718             Small Cell, Ext. PG.                                         Dr. Israel

   S9900             NSCL, Neoadjuvant Carbo/Taxol.                               Dr. Bunn

   S9914             SCL, Ext. Carboplatin/Taxol/Topotecan.                       Dr. Hesketh

   S0003             NSCL, Adv. Taxol/Carbo +/- Tirapazamine.                     Dr. Williamson

   S0004             SCL, Ltd. Tirapazamine.                                      Drs. Le and Williamson

   S0022             NSCL, Stage III. Consolidation Docetaxel.                    Dr. Mudad

   S0027             NSCL, Adv. PS 2 or Elderly Vinorelbine => Docetaxel.         Dr. Hesketh

   S0119             SCL, Ext. CPT-11 / Gemcitabine.                              Dr. Akerley

   S0122             SCL, Ltd. Vaccine Consolidation.                             Dr. Jazieh

   S0126             BAC, Adv. ZD 1839.                                           Dr. West

   S0327             SCL, Ext. PS-341.                                            Dr. Lara

   S0339             NSCLC, Adv, PS-341.                                          Dr. Davies



                                                   Active Studies
                                            Phase II Pilot and Biologic Studies


   S9925             Lung Cancer Specimen Repository Ancillary.                   Drs. Franklin and Gu-
                                                                                  merlock
   S0220             Pancoast, Chemo/RT=>Surgery=>Docetaxel.                      Drs. Kraut and Rusch

   S0222             SCL, Ltd. Tirapazamine.                                      Drs. Le and Williamson

   S0229             NSCL, Resected. Exercise.                                    Dr. Wozniak




APRIL 7 - 10, 2005                            SOUTHWEST ONCOLOGY GROUP                             LUNG     3
    S0310    BAC, Adv. GVAX.                                      Drs. Davies and Roberts

    S0341    NSCL, Adv. PS 2 OSI-774.                             Dr. Hesketh

    S0342    NSCL, Adv. Chemo + C225 Maintenance.                 Dr. Herbst




                                            Phase III Studies


    C30102   Pleural Effusions.                                   Dr. Jumper

    E5597    NSCL, Stage I. Selenium.                             Dr. Kucuk

    JBR19    NSCL, Resected. ZD 1839. NCIC.                       Dr. Vallieres

    R0212    SCL, Ltd. Stage I-IIIB. PCI.                         Dr. Goldberg

    R0214    NSCL, Responders. PCI. RTOG.                         Dr. Gaspar

    S0023    NSCL, Good Risk Stage IIIB. Chemo/RT +/- ZD1839.     Dr. Kelly

    S0124    SCL, Ext. PE vs PI.                                  Dr. Natale



                                        Proposed Studies

    S0424    NSCL, Molecular Epi.                                 Dr. Ambrosone

    S0428    SCL, Ltd. Phase I MGd.                               Dr. Gaspar

    S0429    NSCL, Poor Risk Stage III. Phase I ChemoRT + C225.   Dr. Chen

    S0435    SCL, Ref. Sorafenib.                                 Dr. Gitlitz

    S0436    NSCL, 2nd Line. Avastin + Alimta.                    Dr. Zinner

    S0509    MPM, AZD2171.                                        Dr. Garland

    S0510    SCL, Ext. RPR 116258.                                Dr. Jahanzeb

    S0516    NSCL, Pre vs. Post Op Chemo.                         Dr. Pisters

             BAC, Adv. Alimta.                                    Dr. Davies

             SCL, Ltd. Phase I PE/Velcade/RT.                     Dr. Goldberg

             NSCL, Micro N2.                                      Dr. Albain

             NSCL, Cetuximab.                                     Dr. Kelly




4     LUNG                          SOUTHWEST ONCOLOGY GROUP                    APRIL 7 - 10, 2005
                     Initial Registrations to Therapeutic Studies
                                             by 12 Month Intervals
                                             LUNG COMMITTEE


               900


               800

                                                                         173
               700                                                                               184


               600


               500                                                       273
                        8                                                          142           277

               400     177                           99

                                                                                   172
               300                                                       131
                                     24              143                                         141
                       118
               200                   91
                                                                                   112
                                                     84
                                     66                                  235
               100     179                                                                       186
                                                     109                           118
                                     86
                 0
                     JAN 1999     JAN 2000        JAN 2001            JAN 2002   JAN 2003      JAN 2004
                     DEC 1999     DEC 2000        DEC 2001            DEC 2002   DEC 2003      DEC 2004
                                                       Time of registration
                                MEMBER           AFFILIATE              CCOP        NON-SWOG




APRIL 7 - 10, 2005                        SOUTHWEST ONCOLOGY GROUP                                     LUNG   5
                        Patient Registration by Study and Arm
                                             LUNG COMMITTEE
                                                     July-Dec   Jan-June   July-Dec       All
                                                       2004       2004       2003       Patients

    S9900 NSCLC Surg vs Taxol/CBDCA+Surg
       Pre-Op Chemo
           Surgery Only                                 0             9      13           174
           Preoperative Paclitaxel/CBDCA                0            11      11           180
                                                        0            20      24           354
        Surgery
           Surgery                                      3            18      30           336

    S9925 Lung, Biol, Tissue Repository
           Tissue Collection                           286       241        144         1,401

    S0002 NSCLC Stg I/II Blinded Zyban
       Randomization
           X                                            0             0       3             5
           Y                                            0             0       1             5
                                                        0             0       4            10

    S0023 NSCLC CDDP/VP-16/RT +/- ZD1839
       Induction
           CDDP+VP-16+RT                                95       112         86           588
       Consolidation
           Docetaxel                                    79           68      70           419
       Randomization
           X                                            24           24      27           130
           Y                                            26           23      23           127
                                                        50           47      50           257

    S0124 E-SCLC,CDDP/CPT11 vs CDDP/VP16
       Randomization
           CDDP/CPT-11                                  59           46      33           166
           CDDP/VP16                                    51           47      38           162
                                                       110           93      71           328

    S0220 NSCL,Pancoast,Chemo/RT/Srg
       Induction
           CDDP, VP-16/RT                               3             3       0             6
       Surgery
           Surgery                                      1             2       0             3
       Consolidation Chemo
           Docetaxel                                    1             1       0             2

    S0222 PE/XRT + TPZ for LSCL
       Induction Therapy
           PE/XRT + TPZ                                 15           10       2            27
       Consolidation Therapy
           Cisplatin/Etoposide (PE)                     8             1       0            10

    S0310 BAC Stg IIIB/IV GVAX
           Tumor Procurement                            11            0       0            11
       Vaccine Administration
           Vaccine                                      7             0       0             7




6   LUNG                                  SOUTHWEST ONCOLOGY GROUP                    APRIL 7 - 10, 2005
                        Patient Registration by Study and Arm
                                       LUNG COMMITTEE (Continued)
                                                        July-Dec      Jan-June   July-Dec     All
                                                          2004          2004       2003     Patients

     S0327 Ext SCL, PS-341
            PS-341                                          5              45      10         60

     S0339 NSCLC/CBDA/GEM/PS-341
            CBDCA/GEM/PS-341                              72               48       0       121

     S0341 Adv NSCL OSI-774
        Inital Registration
            OSI-774                                         6               0       0          6

     S0342 NSCL, Adv,Chemo +/-> Cetuximab
        Randomization
            Chemo plus Cetuximab                          21                0       0         21
            Chemo followed by Cetuximab                   21                0       0         21
                                                          42                0       0         42

     C30102 CC, Opt Pleu Eff Control *
            Chest tube                                      1               1       0          2
            Catheter                                        1               1       0          2
                                                            2               2       0          4

     E5597 NSCLC,Stage I,Blinded Selenium *
            Run In Drug                                   24               21      20       122
        Randomization
            Blinded Drug                                  16               21      16       102

     JBR19 NSCLC ZD1839 vs Placebo *
            ZD1839 vs placebo (blind)                     20               24      21         79

     R0212 LSCLC PCI Phase II/III *
        Randomization
            High dose once daily                            2               1       0          3
            Standard dose once daily                        0               0       0          0
            High dose twice daily                           0               0       0          0
                                                            2               1       0          3

     R0214 Proph. Cranial Irrad. vs Obs. *
            PCI                                             1               1       0          2
            Observation                                     2               0       0          2
                                                            3               1       0          4



   * For non-SWOG coordinated studies only SWOG registrations are shown.




APRIL 7 - 10, 2005                       SOUTHWEST ONCOLOGY GROUP                              LUNG    7
                                        S9900 Phase III Intergroup
                                         Coordinating Group: SWOG
         A Randomized Phase III Trial of Surgery Alone or Surgery Plus
    Preoperative Paclitaxel/Carboplatin in Clinical Stage IB (T2N0), II (T1-2N1,
      T3N0) and Selected IIIA (T3N1) Non-Small Cell Lung Cancer (NSCLC)

    Intergroup Participants:                                          Date Activated:
        SWOG, ACOSOG, ECOG, NCCTG, NCIC CTG, RTOG                        10/15/1999
    Study Coordinators:                                               Date Closed:
        P Bunn, K Pisters, E Vallieres, J Treat (ECOG),                   7/15/2004
        R Marks (NCCTG), C Langer (RTOG),
        V Rusch (ACOSOG), F Shepherd (NCIC CTG)
    Statisticians:
        J Crowley, K Chansky
    Data Coordinators:
       C White, K Beasley




                                                        Schema

           R          Surgery
           A
           N
           D
           O
           M
           I
                                                          Progressive Disease                    Off Protocol
           Z
           E          Carboplatin + Paclitaxel

                                                          Responsive/Stable Disease              Surgery

    Objectives                                                        To obtain samples for correlation of radiologic,
    To assess whether preoperative chemotherapy                       pathologic, molecular and biologic factors with
    with paclitaxel and carboplatin for three cycles                  outcome.
    improves survival compared to surgery alone in
                                                                      Patient Population
    previously untreated patients with clinical Stage                 Patients must have histologic or cytologic proof
    IB, II, and IIIA non-small cell lung cancer
                                                                      of T2N0, T1-2N1, or T3N0-1 non-small cell lung
    (NSCLC).                                                          cancer. Patients must not have bronchioalveolar
    To compare the time to progression and sites of                   carcinoma or Stage IIIB tumor involving the su-
    relapse in the two study arms.                                    perior sulcus (Pancoast Tumor).
    To compare operative mortality and other toxici-                  Patients must not have received any prior sys-
    ties in the two study arms.                                       temic chemotherapy or radiation therapy for non-
    To evaluate the response rates (confirmed and                     small cell lung cancer.
    unconfirmed) and the toxicities associated with                   Patients must be at least age 18 and have ade-
    the combination of paclitaxel and carboplatin.                    quate pulmonary, hematologic, and renal func-
                                                                      tion. They must have a SWOG performance
                                                                      status of 0-1. They must not have prior allergic


8     LUNG                                  SOUTHWEST ONCOLOGY GROUP                                    APRIL 7 - 10, 2005

                                                          S9900/III
   reaction to drugs containing cremaphor, post ob-                    one month due to hospitalization for alcohol
   structive pneumonia or other serious infection, or                  abuse. Six patients randomized to the surgery
   other conditions that would preclude protocol                       only arm had major protocol deviations pre-
   treatment.                                                          operatively. Five patients refused their arm as-
                                                                       signment and received pre-operative chemother-
   Stratification/Descriptive Factors
                                                                       apy. One additional patient refused surgery and is
   Treatment randomization will be stratified by
                                                                       not evaluable for toxicity. There have been at
   clinical stage: IB/IIA vs IIB/IIIA.
                                                                       least two treatment-related deaths during chemo-
   Accrual Goals                                                       therapy, one due to infection and one due to an
   Six hundred eligible patients will be accrued to                    LVEF decrease. Another death within 30 days of
   this study. An interim analysis will be performed                   chemotherapy is under review for possible treat-
   after the first 450 patients have been entered, and                 ment-related causes.
   another at completion of accrual.
                                                                       On the surgery step of the pre-operative chemo-
   Summary Statement                                                   therapy arm, a major deviation involved a patient
   Three hundred and fifty-four patients were regis-                   not having mediastinal nodes sampled during
   tered to this study prior to the SWOG Data and                      surgery. There have been seven surgery-related
   Safety Monitoring Committee recommended clo-                        fatalities on the pre-operative chemotherapy arm:
   sure on July 15, 2004 due to recent data showing                    pulmonary embolism and myocardial infarction
   a benefit of post-operative adjuvant chemother-                     (1), infection (1), pulmonary embolism (1), su-
   apy in completely resected NSCLC. Twenty pa-                        praventricular arrhythmia (1), pnuemonia with
   tients are currently listed as ineligible.                          ARDS (1), hemoptysis (1, under review), and one
   There have been six major deviations on the pre-                    death, due to multiple post-operative complica-
   operative chemotherapy step. Two patients ran-                      tions, that is under investigation. There were four
   domized to pre-operative chemotherapy received                      surgery-related deaths on the surgery-only arm:
   surgery but no chemotherapy, and three others                       pulmonary embolism (1), hemorrhage (1),
   withdrew from the study before receiving any                        pnuemonia (1) and another death, due to post-
   treatment. These five patients are not evaluable                    operative complications, that is under investiga-
   for chemotherapy toxicity. One patient on the                       tion.
   chemotherapy arm delayed start of treatment for


                                               Registration by Institution
                                                        Pre-Op Chemo
                                                   Total                                                   Total
          Institutions                             Reg             Institutions                            Reg

          ECOG                                     94              St Elizabeth's MC/Davis, U of CA          4
          NCCTG                                    70              Columbus CCOP                             3
          RTOG                                     26              Providence Everett/Puget Sound            3
          MD Anderson                              19              Scott & White CCOP                        3
          Puget Sound                              17              St Luke's/Mt States/Utah, U of            3
          CTSU                                     11              ACOSOG                                    2
          Davis, U of CA                            9              BAMC/WHMC                                 2
          Oregon Hlth Sci Univ                      8              Los Angeles, U of CA                      2
          Virginia Mason CCOP                       8              Loyola University                         2
          Colorado, U of                            7              New Mexico MBCCOP                         2
          Highlands Onc Group/Arkansas, U of        7              St Joseph's Med Ctr/Davis, U of CA        2
          NCIC CTG                                  6              Sutter Hlth CRG-East/Davis, U of CA       2
          Cincinnati MC, U of                       5              Wayne State Univ                          2
          Columbia River CCOP                       5              All Other Institutions                   26
          Kansas, U of                              4              Total (54 Institutions)                 354




APRIL 7 - 10, 2005                             SOUTHWEST ONCOLOGY GROUP                                            LUNG      9

                                                           S9900/III
                               Registration, Eligibility, and Evaluability
                                                 Randomization
                                         Data as of February 7, 2005
                                                                                             Preoperative
                                                                                              Paclitaxel/
                                                     TOTAL             Surgery Only            CBDCA

            NUMBER REGISTERED                            354                  174                 180
              INELIGIBLE                                  20                    7                  13
              ELIGIBLE                                   334                  167                 167

               RESPONSE ASSESSMENT
                 Determinable                            148                    0                 148
                 Not Determinable                         16                    0                  16
                 Too Early                                 3                    0                   3
                 Not Applicable                          167                  167                   0

               ADVERSE EVENT ASSESSMENT
                 Evaluable                               159                    0                 159
                 Not Evaluable                             5                    0                   5
                 Too Early                                 3                    0                   3
                 Not Applicable                          167                  167                   0


                                        Patient Characteristics
                                                 Randomization
                                         Data as of February 7, 2005
                                                                            Preoperative
                                               Surgery Only               Paclitaxel/CBDCA
                                                 (n=167)                        (n=167)

                   AGE
                     Median               63.9                           65.3
                     Minimum              35.9                           38.4
                     Maximum              82.3                           83.0

                   SEX
                     Males               113             68%            108           65%
                     Females              54             32%             59           35%

                   HISPANIC
                     Yes                   3              2%              3            2%
                     No                  164             98%            164           98%

                   RACE
                     White               143             86%            147           88%
                     Black                13              8%             11            7%
                     Asian                 0              0%              1            1%
                     Native American       1              1%              0            0%
                     Unknown              10              6%              8            5%

                   CLINICAL STAGE
                     IB/IIA              118             71%            117           70%
                     IIB/IIIA             49             29%             50           30%




10   LUNG                              SOUTHWEST ONCOLOGY GROUP                                         APRIL 7 - 10, 2005

                                                     S9900/III
                                                       Treatment Summary
                                                                Pre-Op Chemo
                                                       Data as of February 7, 2005
                                                                                         Preoperative
                                                                                          Paclitaxel/
                                                                                           CBDCA

                                    NUMBER ON PROTOCOL TREATMENT                                   0

                                    NUMBER OFF PROTOCOL TREATMENT                             167
                                      REASON OFF TREATMENT
                                        Treatment completed as planned                        126
                                        Adverse Events or side effects                         13
                                        Refusal unrelated to adverse events                     6
                                        Progression/relapse                                     5
                                        Death                                                   3
                                        Other - not protocol specified                         11

                                        Reason under review                                        3
                                    MAJOR PROTOCOL DEVIATIONS                                      6


                     Number of Patients with a Given Type and Grade of Adverse Event
                                                     Pre-Op Chemo
                               Adverse Events Unlikely or Not Related to Treatment Excluded
                                               Data as of February 7, 2005
                                 Preoperative                                                                    Preoperative
                               Paclitaxel/CBDCA                                                                Paclitaxel/CBDCA
                                     (n=159)                                                                         (n=159)

                                      Grade                                                                          Grade
  ADVERSE EVENT         Unk     0     1      2    3     4   5                  ADVERSE EVENT            Unk     0    1     2    3    4   5

 ADR                      0   157    0       1    0     0   1          Infection                          1   126    0     7   22    2   1
 Cardiovascular           0   131   13       4    9     1   1          Liver                              0   124   31     3    1    0   0
 Clotting                 0   158    1       0    0     0   0          Lung                               3   106   16    28    6    0   0
 Dermatologic             1    39   35      81    3     0   0          Metabolic                          1   109    9    15   20    5   0
 Ear                      0   158    0       1    0     0   0          Musculoskeletal                    0   153    4     1    1    0   0
 Endocrine                0   156    3       0    0     0   0          Neurologic                         1    53   65    24   14    2   0
 Eye                      1   153    0       4    1     0   0          Pain                               0    29   52    61   17    0   0
 Flu-like Symptoms        2    55   64      32    6     0   0          Renal/Bladder                      0   144   13     1    1    0   0
 Gastrointestinal         1    60   56      28   14     0   0
 Hematologic              0    18   30      28   42    41   0          MAXIMUM GRADE
 Hemorrhage               2   148    9       0    0     0   0            ANY ADVERSE EVENT
 Immunological            0   144    7       3    4     1   0          Number                             0     1    5    40   66   44   3


                                      Registration, Eligibility, and Evaluability
                                                       Classified by Treatment Arm
                                                                  Surgery
                                                       Data as of February 7, 2005
                                                                                       Preoperative
                                                                   TOTAL              Chemotherapy            Surgery Only

              NUMBER REGISTERED                                        336                   162                    174
                INELIGIBLE                                              16                    10                      6
                ELIGIBLE                                               320                   152                    168
                  Analyzable, Pend. Elig.                                1                     1                      0

                     ADVERSE EVENT ASSESSMENT
                       Evaluable                                       309                   147                    162
                       Not Evaluable                                     1                     0                      1
                       Too Early                                        10                     5                      5




APRIL 7 - 10, 2005                                    SOUTHWEST ONCOLOGY GROUP                                                  LUNG     11

                                                                   S9900/III
                                               Patient Characteristics
                                               Classified by Treatment Arm
                                                          Surgery
                                                Data as of February 7, 2005
                                              Preoperative Chemotherapy              Surgery Only
                                                        (n=152)                        (n=168)

                      AGE
                        Median                    65.2                          63.8
                        Minimum                   38.7                          35.9
                        Maximum                   83.1                          82.3

                      SEX
                        Males                     97          64%              113             67%
                        Females                   55          36%               55             33%

                      HISPANIC
                        Yes                        3           2%                3              2%
                        No                       149          98%              165             98%

                      RACE
                        White                    133          88%              144             86%
                        Black                      9           6%               13              8%
                        Asian                      2           1%                0              0%
                        Native American            0           0%                1              1%
                        Unknown                    8           5%               10              6%


                                                Treatment Summary
                                               Classified by Treatment Arm
                                                          Surgery
                                                Data as of February 7, 2005
                                                                               Preoperative
                                                            TOTAL             Chemotherapy           Surgery Only

            NUMBER ON PROTOCOL TREATMENT                          2                      2                   0
            NUMBER OFF PROTOCOL TREATMENT                       318                    150                168
              REASON OFF TREATMENT
                Treatment completed as planned                  312                    149                163
                Adverse Events or side effects                    0                      0                  0
                Refusal unrelated to adverse events               1                      0                  1
                Progression/relapse                               0                      0                  0
                Death                                             0                      0                  0
                Other - not protocol specified                    3                      1                  2

                Reason under review                               2                      0                   2
            MAJOR PROTOCOL DEVIATIONS                             7                      1                   6




12   LUNG                                     SOUTHWEST ONCOLOGY GROUP                                           APRIL 7 - 10, 2005

                                                          S9900/III
                     Number of Patients with a Given Type and Grade of Adverse Event
                                             Classified by Treatment Arm
                                                        Surgery
                             Adverse Events Unlikely or Not Related to Treatment Excluded
                                             Data as of February 7, 2005
                                              Preoperative Chemotherapy                     Surgery Only
                                                        (n=147)                               (n=162)

                                                       Grade                                   Grade
             ADVERSE EVENT                            Unk      0   1   2   3   4 5            Unk      0   1   2   3   4 5

 ADR                                                     0   146    0 0 0 0 1                   0   161     0 0 0 0 1
 Cardiovascular                                          0   110    6 5 18 5 3                  0   127     7 5 21 1 1
 Clotting                                                0   146    1 0 0 0 0                   0   158     3 0 1 0 0
 Dermatologic                                            0   143    2 2 0 0 0                   0   154     2 3 3 0 0
 Flu-like Symptoms                                       0   105   34 6 2 0 0                   0   116    34 9 3 0 0
 Gastrointestinal                                        0   128    8 7 3 1 0                   0   135    18 7 2 0 0
 Hematologic                                             0    72   16 24 35 0 0                 1    85    33 21 21 1 0
 Hemorrhage                                              0   142    0 0 3 1 1                   1   154     0 0 4 2 1
 Infection                                               0   129    0 2 11 3 2                  1   144     0 4 8 4 1
 Liver                                                   0   144    2 0 0 1 0                   0   153     3 4 2 0 0
 Lung                                                    1    78   12 19 26 10 1                0    94    13 25 20 10 0
 Metabolic                                               0   129   10 1 6 1 0                   0   137    11 4 10 0 0
 Musculoskeletal                                         0   145    0 2 0 0 0                   0   162     0 0 0 0 0
 Neurologic                                              0   132    8 5 2 0 0                   1   145     9 4 2 1 0
 Pain                                                    0   117    5 11 14 0 0                 1   117    16 15 13 0 0
 Renal/Bladder                                           0   140    4 2 1 0 0                   0   153     6 3 0 0 0

 MAXIMUM GRADE ANY ADVERSE
 EVENT
 Number                                                  0    26 16 31 58      9 7              0    27 28 36 56 11 4




APRIL 7 - 10, 2005                          SOUTHWEST ONCOLOGY GROUP                                           LUNG      13

                                                       S9900/III
                                                       S9925 Biologic
                        Lung Cancer Specimen Repository Protocol, Ancillary

     Study Coordinators:                                                 Date Activated:
        W Franklin, P Gumerlock, D Gandara                                  9/1/2000
     Statisticians:
         J Crowley, K Chansky
     Data Coordinator:
        C White



     Objectives                                                         protocol. Those subsequently found to ineligible
     To establish a central lung cancer specimen re-                    for the therapeutic study will be declared ineligi-
     pository to serve as a resource for current and fu-                ble for this ancillary study as well. Patients must
     ture scientific studies.                                           have adequate diagnostic tissue available, as de-
                                                                        fined in the protocol.
     To utilize the Southwest Oncology Group clinical
     data base to perform clinicopathologic correlation                 Accrual Goals
     with the results of those studies.                                 The establishment of the Lung Tumor Repository
     To test new hypotheses as they emerge.                             is viewed as a long-term, ongoing project. Prior
                                                                        to the use of tissue samples from this repository, a
     Patient Population                                                 formal study proposal must be written and ap-
     Patients must be enrolled in a Southwest Oncol-                    proved by the Lung Committee.
     ogy Group coordinated, lung cancer treatment


                                               Registration by Institution
                                            Registrations ending December 31, 2004
                                               Total                                                          Total
         Institutions                          Reg            Institutions                                    Reg

         CTSU                                  179            Thompson Ca Surv Ctr/San Antonio, U of TX         16
         Wichita CCOP                           89            Kansas City CCOP                                  14
         Columbus CCOP                          64            Cleveland Clinic OH                               13
         Davis, U of CA                         52            S Georgia Med Ctr/BAMC/WHMC                       13
         NCIC CTG                               46            Scott & White CCOP                                13
         ECOG                                   45            Arkansas, U of                                    12
         LSU-Shreveport                         41            Atlanta Reg CCOP                                  12
         Southeast CCC CCOP                     41            Highlands Onc Group/Arkansas, U of                12
         Montana CCOP                           37            St Elizabeth's MC/Davis, U of CA                  12
         Grand Rapids CCOP                      34            Dayton CCOP                                       11
         Central IL CCOP                        27            Kaiser, Sacramento/Davis, U of CA                 11
         Henry Ford Hosp                        27            Rochester, Univ of                                11
         Loyola University                      27            New Mexico MBCCOP                                 10
         Upstate Carolina                       27            Sutter Hlth Western/Davis, U of CA                10
         Ozarks Reg CCOP                        25            SW Cancer & Res Ctr/San Antonio, U of TX          10
         So Calif, U of                         24            Utah, U of                                        10
         Kansas, U of                           23            Boston Univ Med Ctr                                9
         Puget Sound                            23            City of Hope Med Ctr                               8
         Colorado, U of                         22            Marquette Gen Hosp/Wayne State Univ                8
         St Louis CCOP                          20            San Antonio, U of TX                               8
         BAMC/WHMC                              19            South Texas Onc/Hem/San Antonio, U of TX           8
         Hawaii MBCCOP, U of                    19            Virginia Mason CCOP                                8
         Northwest CCOP                         18            All Other Institutions                           217
         St Francis/Stormont/Kansas, U of       16            Total (134 Institutions)                       1,401




14     LUNG                                     SOUTHWEST ONCOLOGY GROUP                                     APRIL 7 - 10, 2005

                                                         S9925/BIOLOGIC
                                        S0023 Phase III Intergroup
                                          Coordinating Group: SWOG
     A Phase III Trial of Cisplatin/Etoposide/Radiotherapy with Consolidation
     Docetaxel Followed by Maintenance Therapy with ZD 1839 or Placebo in
     Patients with Inoperable Locally Advanced Stage III Non-Small Cell Lung
                                       Cancer

   Intergroup Participants:                                        Date Activated:
       SWOG, NCCTG (S0023), NCIC CTG (BR15)                           6/15/2001
   Study Coordinators:
       K Kelly, K Albain, D Gandara, L Gaspar, J Jett (NCCTG),
       Y Ung (NCIC CTG)
   Statisticians:
       J Crowley, K Chansky
   Data Coordinator:
      C White




                                                       Schema

          R
          E
                                                                           R          ZD 1839
          G                                       R
                                                                           A          Maintenance
          I                                       E
                                                                           N
          S                                       G
                                                                           D
          T                                       I
                     Cisplatin / Etoposide + RT            Docetaxel       O
                                                                                      (Double Blinded)
          R                                       S
                                                                           M
          A                                       T
                                                                           I
          T                                       E
                                                                           Z
          I                                       R
                                                                           E          Placebo
          O
          N

   Objectives                                                      Patient Population
   To assess whether maintenance therapy with ZD                   Patients must have histologic or cytologic proof
   1839 as compared to placebo following induction                 of unresectable Stage IIIA (N2) or Stage IIIB
   cisplatin/etoposide/radiotherapy plus consolida-                non-small cell lung cancer. If Stage IIIA, the pa-
   tion docetaxel improves overall survival and pro-               tient must have unresectable disease with N2
   gression-free survival in patients with unre-                   status and multiple and/or bulky mediastinal
   sectable Stage III non-small cell lung cancer                   nodes, and must not be eligible to participate in
   (NSCLC).                                                        S9336. Patients must not have malignant pleural
                                                                   effusions or pericardial effusions.
   To describe the toxicity profile of long term ad-
   ministration of ZD 1839.                                        Patients must not have received any prior chemo-
   To obtain samples for correlative studies as out-               therapy, radiation therapy, or surgical resection
                                                                   for lung cancer.
   lined in S9925.
                                                                   Patients must have adequate hematologic, renal,
                                                                   and pulmonary function, and a Zubrod perform-
                                                                   ance status of 0-1.


APRIL 7 - 10, 2005                           SOUTHWEST ONCOLOGY GROUP                                        LUNG       15

                                                       S0023/III
     Stratification/Descriptive Factors                                embolism (1); RT late lung morbidity (1);
     At the time of randomization patients will be                     hemoptysis (1); and cardiac failure with hypoxia
     stratified by (1) stage: IIIA vs IIIB, (2) disease                (1). Another death within 30 days of treatment is
     status: measurable vs non-measurable, and (3)                     under review for possible treatment-related
     histologic/cytologic subtype: squamous vs non-                    causes. In addition, one ineligible patient died
     squamous.                                                         due to respiratory infection with neutropenia.
     Accrual Goals                                                     On the consolidation step, three patients never
     Eight hundred and forty eligible patients will be                 started consolidation treatment, a major devia-
     accrued to this study. An interim analysis will be                tion, and are not evaluable for toxicity. There
     performed after the first 400 eligible patients                   have been at least thirteen deaths due to treat-
     have been entered, and another at completion of                   ment-related causes on consolidation: dyspnea
     accrual.                                                          and late RT morbidity (1); neutropenia, infection,
                                                                       dyspnea, sinus bradycardia and anorexia (1); res-
     Summary Statement
                                                                       piratory infection with alveolar damage (1); respi-
     This study has accrued 588 patients as of Decem-
                                                                       ratory infection without neutropenia (1); respira-
     ber 31, 2004, of whom 44 are currently listed as
                                                                       tory infection with neutropenia (1); respiratory in-
     ineligible. Three-hundred seventy-one eligible
                                                                       fection with pneumonitis (2); pulmonary fibrosis
     patients have proceeded to docetaxel consolida-
                                                                       with pneumonitis (1); pneumonitis (2); late RT
     tion, and 222 have been randomized to the main-
                                                                       morbidity (1); flu-like symptoms (1); CNS hem-
     tenance step.
                                                                       orrhage (1). Another death within 30 days of
     On the concurrent chemoradiotherapy portion, 14                   treatment is under review for possible treatment-
     patients never started treatment, a major devia-                  related causes.
     tion, and are not evaluable for toxicity. Another
                                                                       Nine patients never started maintenance therapy,
     patient went off treatment after one day of che-
                                                                       all major deviations, and are not evaluable for
     motherapy, also a major deviation. There were
                                                                       toxicity. One additional patient received the
     nine other cases with major deviations from pro-
                                                                       wrong maintenance treatment, also a major devia-
     tocol radiotherapy guidelines. There have been at
                                                                       tion. There have been two deaths on the mainte-
     least ten deaths due to treatment-related causes on
                                                                       nance step, one due to pulmonary embolism with
     concurrent therapy: dyspnea (1); respiratory in-
                                                                       dyspnea and one due to infection with unknown
     fection without neutropenia (1); respiratory infec-
                                                                       ANC.
     tion with neutropenia (2); respiratory infection
     with unknown ANC (1); respiratory infection
     with unknown ANC and dyspnea (1); pulmonary




16     LUNG                                    SOUTHWEST ONCOLOGY GROUP                                     APRIL 7 - 10, 2005

                                                           S0023/III
                                      Initial Registrations By 3 Month Intervals

                  70



                  60



                  50



                  40



                  30                                                                                     60
                                                                     56
                                                                            51                     52            53
                                                    46                              48
                                            42                                                                           43
                  20                  38                       40                           38


                  10          18


                        3
                  0
                       JUL    OCT    JAN    APR    JUL      OCT JAN APR             JUL    OCT    JAN    APR    JUL     OCT
                       SEP    DEC    MAR    JUN    SEP      DEC MAR JUN             SEP    DEC    MAR    JUN    SEP     DEC
                       2001   2001   2002   2002   2002     2002 2003 2003 2003            2003   2004   2004   2004    2004
                                                                Time of Registration
                                                                    CDDP+VP-16+RT



                                                   Registration by Institution
                                                            Initial Registration
                                              Registrations ending December 31, 2004
                                                          Total                                                                Total
   Institutions                                           Reg               Institutions                                       Reg

   NCCTG                                                  86                Kaiser, Sacramento/Davis, U of CA                    7
   NCIC CTG                                               53                Kansas City CCOP                                     7
   CTSU                                                   51                Montana CCOP                                         7
   Wichita CCOP                                           20                Southeast CCC CCOP                                   7
   Davis, U of CA                                         19                Thompson Ca Surv Ctr/San Antonio, U of TX            7
   Greenville CCOP                                        18                Utah, U of                                           7
   Columbus CCOP                                          17                Northwest CCOP                                       6
   Loyola University                                      14                Ozarks Reg CCOP                                      6
   Upstate Carolina                                       14                Gulf Coast MBCCOP                                    5
   LSU-Shreveport                                         11                Sutter Hlth Western/Davis, U of CA                   5
   Columbia River CCOP                                    10                Virginia Mason CCOP                                  5
   Grand Rapids CCOP                                      10                Wayne State Univ                                     5
   Highlands Onc Group/Arkansas, U of                     10                Hawaii MBCCOP, U of                                  4
   Atlanta Reg CCOP                                        8                Marquette Gen Hosp/Wayne State Univ                  4
   City of Hope Med Ctr                                    8                Methodist, Dallas/San Antonio, U of TX               4
   Colorado, U of                                          8                Mt Clemens Gen Hosp/Wayne State Univ                 4
   Kansas, U of                                            8                Shasta Reg Med Ctr/Davis, U of CA                    4
   South Texas Onc/Hem/San Antonio, U of TX                8                St Joseph's Med Ctr/Davis, U of CA                   4
   BAMC/WHMC                                               7                All Other Institutions                              96
   Cleveland Clinic OH                                     7                Total (90 Institutions)                            588
   Dayton CCOP                                             7




APRIL 7 - 10, 2005                                 SOUTHWEST ONCOLOGY GROUP                                                    LUNG    17

                                                                    S0023/III
                                     Registration, Eligibility, and Evaluability
                                                         Initial Registration
                            Registrations ending December 31, 2004; Data as of February 7, 2005
                                              CDDP+VP-                                                           CDDP+VP-
                                               16+RT                                                              16+RT

     NUMBER REGISTERED                             588                 ADVERSE EVENT ASSESSMENT
       INELIGIBLE                                   44                   Evaluable                                    456
       ELIG./ PEND. ELIG.                          544                   Not Evaluable                                 14
         Analyzable, Pend. Elig.                    35                   Too Early                                     74

          RESPONSE ASSESSMENT
            Determinable                           356
            Not Determinable                        36
            Too Early                              134
            Not Applicable                          18


                                                 Patient Characteristics
                                                         Initial Registration
                            Registrations ending December 31, 2004; Data as of February 7, 2005
                                      CDDP+VP-16+RT                                              CDDP+VP-16+RT
                                         (n=544)                                                    (n=544)
               AGE                                                RACE
                 Median               61.6                          White                       497       91%
                 Minimum              20.0                          Black                        34        6%
                 Maximum              83.0                          Asian                         7        1%
                                                                    Pacific Islander              1        0%
               SEX                                                  Native American               1        0%
                 Males               375           69%              Multi-Racial                  4        1%
                 Females             169           31%

               HISPANIC
                 Yes                  10            2%
                 No                  534           98%


                                                   Treatment Summary
                                                         Initial Registration
                            Registrations ending December 31, 2004; Data as of February 7, 2005
                                                                                       CDDP+VP-
                                                                                        16+RT

                                   NUMBER ON PROTOCOL TREATMENT                            48

                                   NUMBER OFF PROTOCOL TREATMENT                          496
                                     REASON OFF TREATMENT
                                       Treatment completed as planned                     364
                                       Adverse Events or side effects                      21
                                       Refusal unrelated to adverse events                  8
                                       Progression/relapse                                  6
                                       Death                                                7
                                       Other - not protocol specified                      30

                                       Reason under review                                 60
                                   MAJOR PROTOCOL DEVIATIONS                               24




18   LUNG                                       SOUTHWEST ONCOLOGY GROUP                                          APRIL 7 - 10, 2005

                                                               S0023/III
                     Number of Patients with a Given Type and Grade of Adverse Event
                                                    Initial Registration
                              Adverse Events Unlikely or Not Related to Treatment Excluded
                            Registrations ending December 31, 2004; Data as of February 7, 2005
                                 CDDP+VP-16+RT                                                                      CDDP+VP-16+RT
                                    (n=456)                                                                            (n=456)

                                        Grade                                                                              Grade
  ADVERSE EVENT         Unk      0      1      2      3     4     5                  ADVERSE EVENT           Unk     0     1      2     3    4     5

 ADR                        0   455   0   0   0             0     1         Liver                              2   374    52 22         6    0     0
 Cardiovascular             2   327 40 37 35               13     2         Lung                               4   258    69 100       17    4     4
 Clotting                   0   455   1   0   0             0     0         Metabolic                          0   331    59 34        29    3     0
 Dermatologic               2   170 113 164   7             0     0         Musculoskeletal                    1   435     9   6        4    1     0
 Ear                        0   440   6   8   2             0     0         Neurologic                         1   309    88 42        14    2     0
 Endocrine                  0   448   7   1   0             0     0         Pain                               2   268    92 63        30    1     0
 Eye                        2   435   9   9   1             0     0         Renal/Bladder                      2   409    32 10         3    0     0
 Flu-like Symptoms          2    78 170 159 39              7     1         Sexual/Reproductive Function       0   455     1   0        0    0     0
 Gastrointestinal           4    35 137 144 124            12     0         Syndromes                          0   455     0   1        0    0     0
 Hematologic                1    50 48 106 152             99     0
 Hemorrhage                 1   429 25    0   0             0     1         MAXIMUM GRADE
 Immunological              0   439 13    4   0             0     0           ANY ADVERSE EVENT
 Infection                  5   341   7 24 67               7     5         Number                             2     9    22     90 208 114       11


                                        Registration, Eligibility, and Evaluability
                                                                      Consolidation
                            Registrations ending December 31, 2004; Data as of February 7, 2005
                                                          Docetaxel                                                            Docetaxel

          NUMBER REGISTERED                                 420                  ADVERSE EVENT ASSESSMENT
            INELIGIBLE                                       49                    Evaluable                                     307
            ELIG./ PEND. ELIG.                              371                    Not Evaluable                                   5
              Analyzable, Pend. Elig.                        24                    Too Early                                      59

               RESPONSE ASSESSMENT
                 Determinable                               239
                 Not Determinable                             9
                 Too Early                                  115
                 Not Applicable                               8


                                                          Patient Characteristics
                                                                      Consolidation
                            Registrations ending December 31, 2004; Data as of February 7, 2005
                                                   Docetaxel                                                 Docetaxel
                                                    (n=371)                                                   (n=371)
                AGE                                                          RACE
                  Median                    62.1                               White                   342               92%
                  Minimum                   24.6                               Black                    22                6%
                  Maximum                   83.2                               Asian                     5                1%
                                                                               Pacific Islander          1                0%
                SEX                                                            Multi-Racial              1                0%
                  Males                 243                    65%
                  Females               128                    35%

                HISPANIC
                  Yes                     7                     2%
                  No                    364                    98%




APRIL 7 - 10, 2005                                        SOUTHWEST ONCOLOGY GROUP                                                         LUNG    19

                                                                         S0023/III
                                                    Treatment Summary
                                                             Consolidation
                          Registrations ending December 31, 2004; Data as of February 7, 2005
                                                                                      Docetaxel

                                    NUMBER ON PROTOCOL TREATMENT                         39
                                    NUMBER OFF PROTOCOL TREATMENT                       332
                                      REASON OFF TREATMENT
                                        Treatment completed as planned                  252
                                        Adverse Events or side effects                   17
                                        Refusal unrelated to adverse events               2
                                        Progression/relapse                              15
                                        Death                                             7
                                        Other - not protocol specified                    9

                                        Reason under review                              30
                                    MAJOR PROTOCOL DEVIATIONS                             3


                     Number of Patients with a Given Type and Grade of Adverse Event
                                                    Consolidation
                            Adverse Events Unlikely or Not Related to Treatment Excluded
                          Registrations ending December 31, 2004; Data as of February 7, 2005
                                   Docetaxel                                                                  Docetaxel
                                    (n=307)                                                                    (n=307)

                                    Grade                                                                      Grade
     ADVERSE EVENT      Unk    0    1    2     3     4   5                  ADVERSE EVENT         Unk     0    1    2      3    4    5

 ADR                      0   306   0   0       0   0    1          Infection                       3   202    5   21     60   10    6
 Cardiovascular           3   229 39 18        13   4    1          Liver                           2   248   35   14      8    0    0
 Clotting                 0   306   0   0       1   0    0          Lung                           10   141   30   75     36    7    8
 Dermatologic             0   210 41 54         2   0    0          Metabolic                       0   217   40   28     19    3    0
 Ear                      0   297   3   7       0   0    0          Musculoskeletal                 2   293    7    3      1    1    0
 Endocrine                0   301   5   1       0   0    0          Neurologic                      2   191   82   27      5    0    0
 Eye                      0   294   7   5       1   0    0          Pain                            2   170   67   57     10    1    0
 Flu-like Symptoms        4    80 103 101      16   2    1          Renal/Bladder                   0   290   13    3      1    0    0
 Gastrointestinal         1   109 111 57       26   2    1
 Hematologic              0    42 38 35        71 120    1          MAXIMUM GRADE
 Hemorrhage               0   296 10    0       0   0    1            ANY ADVERSE EVENT
 Immunological            1   294   8   2       2   0    0          Number                          0     6   15   58     92 122    14




20     LUNG                                        SOUTHWEST ONCOLOGY GROUP                                        APRIL 7 - 10, 2005

                                                                S0023/III
                                           Maintenance By 3 Month Intervals

               30




                                                                            11
                                               13
               20                                                                                           16
                                      13               12
                                                                                              14     9
                                                                                                                  10
                                                                                  12



                                                                10
               10
                               5                                            17
                                               15
                                      13               13                                            13
                                                                                              11            12    12
                                                                                  10
                      2        6                                 6
                      2
                0
                     JAN     APR     JUL     OCT      JAN      APR       JUL      OCT        JAN    APR    JUL    OCT
                     MAR     JUN     SEP     DEC      MAR       JUN      SEP      DEC        MAR    JUN    SEP    DEC
                     2002    2002    2002    2002     2003     2003     2003      2003       2004   2004   2004   2004
                                                             Time of Registration
                                       X                                                 Y



                                     Registration, Eligibility, and Evaluability
                                                             Maintenance
                            Registrations ending December 31, 2004; Data as of February 7, 2005
                                                                      TOTAL                  X              Y

                     NUMBER REGISTERED                                 257               130               127
                       INELIGIBLE                                       35                14                21
                       ELIGIBLE                                        222               116               106
                         Analyzable, Pend. Elig.                        17                 9                 8

                            RESPONSE ASSESSMENT
                              Determinable                             114                   55             59
                              Not Determinable                           7                    6              1
                              Too Early                                 95                   50             45
                              Not Applicable                             6                    5              1

                            ADVERSE EVENT ASSESSMENT
                              Evaluable                                183                   95             88
                              Not Evaluable                              9                    7              2
                              Too Early                                 30                   14             16




APRIL 7 - 10, 2005                                 SOUTHWEST ONCOLOGY GROUP                                              LUNG   21

                                                                S0023/III
                                        Patient Characteristics
                                                   Maintenance
                   Registrations ending December 31, 2004; Data as of February 7, 2005
                                                      X                           Y
                                                   (n=116)                     (n=106)

              AGE
                Median                      61.7                        61.3
                Minimum                     24.8                        37.7
                Maximum                     79.6                        81.4

              SEX
                Males                       78               67%        65               61%
                Females                     38               33%        41               39%

              HISPANIC
                Yes                         0                  0%        1                1%
                No                        116                100%      105               99%

              RACE
                White                     112                97%        92               87%
                Black                       4                 3%        10                9%
                Asian                       0                 0%         2                2%
                Pacific Islander            0                 0%         1                1%
                Multi-Racial                0                 0%         1                1%

              STAGE
                IIIA                        65               56%        58               55%
                IIIB                        51               44%        48               45%

              DISEASE STATUS
                Measurable                112                97%       103               97%
                NonMBL                      4                 3%         3                3%

              HISTOLOGY
                Squamous cell               52               45%        49               46%
                Non-squamous cell           64               55%        57               54%


                                         Treatment Summary
                                                   Maintenance
                   Registrations ending December 31, 2004; Data as of February 7, 2005
                                                              TOTAL       X                    Y

            NUMBER ON PROTOCOL TREATMENT                       101       49                    52
            NUMBER OFF PROTOCOL TREATMENT                      121       67                    54
              REASON OFF TREATMENT
                Adverse Events or side effects                    13     10                     3
                Refusal unrelated to adverse events                4      3                     1
                Progression/relapse                               69     33                    36
                Death                                              6      4                     2
                Other - not protocol specified                     9      7                     2

                Reason under review                               18     10                     8
            MAJOR PROTOCOL DEVIATIONS                             10      8                     2




22   LUNG                              SOUTHWEST ONCOLOGY GROUP                                     APRIL 7 - 10, 2005

                                                      S0023/III
                     Number of Patients with a Given Type and Grade of Adverse Event
                                                     Maintenance
                             Adverse Events Unlikely or Not Related to Treatment Excluded
                           Registrations ending December 31, 2004; Data as of February 7, 2005
                                                               X                                    Y
                                                             (n=95)                               (n=88)

                                                              Grade                               Grade
                ADVERSE EVENT                     Unk    0    1       2    3   4   5   Unk    0    1    2    3    4     5

  Cardiovascular                                    0   83    5       4    2   0   1     1   72    8    3    2    2     0
  Clotting                                          0   94    0       0    1   0   0     0   88    0    0    0    0     0
  Dermatologic                                      0   33   32      24    6   0   0     0   59   21    8    0    0     0
  Endocrine                                         0   93    1       0    1   0   0     0   87    0    1    0    0     0
  Eye                                               0   80    8       6    1   0   0     0   82    5    1    0    0     0
  Flu-like Symptoms                                 0   52   23      17    3   0   0     1   47   27   13    0    0     0
  Gastrointestinal                                  0   44   25      16    8   2   0     2   51   29    6    0    0     0
  Hematologic                                       0   63   22       6    3   1   0     0   59   22    6    1    0     0
  Hemorrhage                                        0   91    4       0    0   0   0     0   87    1    0    0    0     0
  Immunological                                     0   92    3       0    0   0   0     0   84    4    0    0    0     0
  Infection                                         1   84    1       4    4   0   1     0   78    2    6    2    0     0
  Liver                                             0   74   15       6    0   0   0     0   79    9    0    0    0     0
  Lung                                              0   60    7      19    7   1   1     2   57    8   19    2    0     0
  Metabolic                                         0   89    4       1    1   0   0     0   82    6    0    0    0     0
  Musculoskeletal                                   0   93    1       0    0   1   0     0   85    2    1    0    0     0
  Neurologic                                        0   74   13       7    1   0   0     0   68   12    5    3    0     0
  Pain                                              0   76   11       7    1   0   0     1   66   12    8    1    0     0
  Renal/Bladder                                     0   86    8       1    0   0   0     0   85    3    0    0    0     0
  Sexual/Reproductive Function                      0   94    0       1    0   0   0     0   87    0    1    0    0     0

  MAXIMUM GRADE ANY ADVERSE EVENT
  Number                                            0    7   19      35   29   3   2     1   16   24   35   10    2     0




APRIL 7 - 10, 2005                           SOUTHWEST ONCOLOGY GROUP                                            LUNG       23

                                                         S0023/III
                                                    S0027 Phase II
       Phase II Trial of Sequential Vinorelbine and Docetaxel in Advanced Non-
           Small Cell Lung Cancer Patients Age Seventy and Older or with
                                 Performance Status 2

     Study Coordinator:                                               Date Activated:
        P Hesketh                                                        9/1/2001
     Statisticians:                                                   Date Closed:
         K Chansky, J Crowley                                             7/1/2003
     Data Coordinator:
        V Green



     Objectives                                                       measurable sites of disease (e.g. painful bone me-
     To assess survival in patients with advanced non-                tastases) are allowed.
     small cell lung carcinoma age seventy and older                  Patients must have normal hematologic, hepatic,
     with Zubrod performance status of 0-1 or with                    renal, and cardiac function. Patients must either
     Zubrod performance status of 2 and of any age,                   be age 70 or older with a performance status of 0-
     treated with vinorelbine followed by docetaxel.                  1 or have a performance status of 2, at any age.
     To evaluate the objective tumor response rates
                                                                      Stratification/Descriptive Factors
     (confirmed plus unconfirmed, complete and par-                   Patients will be stratified by: age 70 or older and
     tial), in patients with advanced non-small cell
                                                                      performance status 0-1 vs. performance status 2,
     lung carcinoma treated with vinorelbine followed                 any age.
     by docetaxel in the subset of patients with meas-
     urable disease.                                                  Cancer Control Credits
                                                                      The NCI Division of Cancer Prevention and Con-
     To evaluate dose delivered, patient report of func-
                                                                      trol has assigned 0.5 cancer control credits for
     tional and symptom status and toxicities associ-
                                                                      each registration to this study.
     ated with these two drugs in this group of patients
     with advanced non-small cell lung cancer.                        Accrual Goals
                                                                      Fifty-five eligible patients age 70 and older with
     To investigate the feasibility of performing phar-
                                                                      performance status 0-1 and 40 eligible patients
     macokinetic studies and obtaining preliminary
                                                                      with performance status 2 (any age) will be ac-
     pharmacokinetic data on this group of patients
                                                                      crued to this study (95 patients total).
     with advanced non-small cell lung cancer.
                                                                      Summary Statement
     Patient Population                                               This trial closed on July 1, 2003, having accrued
     Patients must have histologically or cytologically
                                                                      125 patients, 79 age 70 and older with perform-
     proven newly diagnosed Stage IIIB or Stage IV
                                                                      ance status 0-1 and 46 with performance status 2,
     primary non-small cell lung cancer or recurrent
                                                                      any age. Eight patients are currently listed as in-
     disease after previous surgery and/or irradiation.
                                                                      eligible. One other patient never started protocol
     Patients with brain metastases are not eligible for
                                                                      treatment and is not analyzable.
     this study. Patients with bronchioloalveolar carci-
     noma or Stage IIIB tumor involving the superior                  There have been at least three treatment-related
     sulcus (Pancoast Tumors) are not eligible.                       deaths, one due to dyspnea, one due to pneumoni-
                                                                      tis, and one due to dyspnea and somnolence. One
     Patients must not have received prior systemic
                                                                      additional death within 30 days of treatment is
     therapy or biologic therapy for non-small cell
                                                                      under review for possible treatment-related
     lung cancer. There must not be plans for concur-
                                                                      causes.
     rent hormonal, biologic or radiation therapy to
     measurable lesions. Plans for concurrent pallia-
     tive radiation therapy to small field non-



24     LUNG                                    SOUTHWEST ONCOLOGY GROUP                                   APRIL 7 - 10, 2005

                                                           S0027/II
                                            Registration by Institution
                                                Total                                                             Total
       Institutions                             Reg           Institutions                                        Reg

       Ozarks Reg CCOP                           9            Cancer Care NW/Puget Sound                            2
       Dayton CCOP                               8            Gulf Coast MBCCOP                                     2
       Henry Ford Hosp                           8            Hem/Onc Associates/Utah, U of                         2
       Grand Rapids CCOP                         6            Puget Sound                                           2
       Columbus CCOP                             5            Quad Cities/Genesis/Loyola University                 2
       Greenville CCOP                           5            St Elizabeth's MC/Davis, U of CA                      2
       Oakwood Hospital/Michigan, U of           5            St Francis/Stormont/Kansas, U of                      2
       Southeast CCC CCOP                        5            Upstate Carolina                                      2
       St Louis CCOP                             5            Utah, U of                                            2
       Wichita CCOP                              5            Akron Gen Med Ctr/Cleveland Clinic OH                 1
       Colorado, U of                            4            BAMC/WHMC                                             1
       Davis, U of CA                            4            City of Hope Med Ctr                                  1
       Kansas, U of                              4            Finger Lakes Hem/Onc/Rochester, Univ of               1
       Loyola University                         3            Med City Dallas Hosp/San Antonio, U of TX             1
       LSU-Shreveport                            3            Mem Hosp, Co Springs/Colorado, U of                   1
       Montana CCOP                              3            S Georgia Med Ctr/BAMC/WHMC                           1
       Northwest CCOP                            3            Scott & White CCOP                                    1
       Providence Hosp                           3            St Anthony Hospital/Colorado, U of                    1
       Rochester, Univ of                        3            St Louis University                                   1
       Santa Rosa CCOP                           3            Western Reg CCOP                                      1
       Breslin Cancer Ctr/Henry Ford Hosp        2            Total (41 Institutions)                             125


                                     Registration, Eligibility, and Evaluability
                                                   Classified by Group
                                                 Data as of January 1, 2005
                                                                                   Age
                                                           TOTAL              >=70 & PS 0-1       PS 2, Any Age

              NUMBER REGISTERED                               125                    79                   46
                INELIGIBLE                                      8                     5                    3
                ELIGIBLE                                      117                    74                   43
                  Not Analyzable                                1                     1                    0

                      BASELINE DISEASE STATUS
                        Measurable                            107                    69                   38
                        Non Measurable                          4                     4                    0
                        Not Evaluable                           5                     0                    5

                      RESPONSE ASSESSMENT
                        Determinable                           91                    60                   31
                        Not Determinable                       16                    11                    5
                        Too Early                               4                     2                    2
                        Not Applicable                          5                     0                    5

                      ADVERSE EVENT ASSESSMENT
                        Evaluable                             116                    73                   43




APRIL 7 - 10, 2005                           SOUTHWEST ONCOLOGY GROUP                                                   LUNG   25

                                                          S0027/II
                                               Patient Characteristics
                                                   Classified by Group
                                                 Data as of January 1, 2005
                                               Age >=70 & PS 0-1                   PS 2, Any Age
                                                    (n=73)                             (n=43)

                         AGE
                           Median              75.7                           73.2
                           Minimum             70.0                           44.1
                           Maximum             87.5                           84.8

                         SEX
                           Males               38          52%                25               58%
                           Females             35          48%                18               42%

                         HISPANIC
                           Yes                  1           1%                 0               0%
                           No                  72          99%                43             100%

                         RACE
                           White               65          89%                37               86%
                           Black                8          11%                 6               14%


                                                Treatment Summary
                                                   Classified by Group
                                                 Data as of January 1, 2005
                                                                                    Age
                                                            TOTAL              >=70 & PS 0-1         PS 2, Any Age

            NUMBER ON PROTOCOL TREATMENT                             0                   0                   0
            NUMBER OFF PROTOCOL TREATMENT                          116                  73                  43
              REASON OFF TREATMENT
                Treatment completed as planned                      51                  35                  16
                Adverse Events or side effects                      18                  14                   4
                Refusal unrelated to adverse events                  5                   3                   2
                Progression/relapse                                 23                  10                  13
                Death                                               11                   6                   5
                Other - not protocol specified                       8                   5                   3

                Reason under review                                  0                   0                   0
            MAJOR PROTOCOL DEVIATIONS                                0                   0                   0




26   LUNG                                     SOUTHWEST ONCOLOGY GROUP                                           APRIL 7 - 10, 2005

                                                           S0027/II
                     Number of Patients with a Given Type and Grade of Adverse Event
                                                 Classified by Group
                             Adverse Events Unlikely or Not Related to Treatment Excluded
                                             Data as of January 1, 2005
                                                   Age >=70 & PS 0-1                        PS 2, Any Age
                                                        (n=73)                                  (n=43)

                                                        Grade                                  Grade
             ADVERSE EVENT                              Unk    0    1    2   3   4 5          Unk    0   1   2   3   4 5

 ADR                                                      0   73    0    0    0 0 0              0   42 0 0 0        0   1
 Cardiovascular                                           0   37   16   12    7 1 0              0   18 8 9 6        2   0
 Clotting                                                 0   72    1    0    0 0 0              0   42 0 0 1        0   0
 Dermatologic                                             0   41   22    9    1 0 0              0   32 5 5 1        0   0
 Endocrine                                                0   73    0    0    0 0 0              0   42 0 0 1        0   0
 Eye                                                      0   71    1    1    0 0 0              0   41 1 1 0        0   0
 Flu-like Symptoms                                        0    3   30   24   14 2 0              0   11 6 17 8       1   0
 Gastrointestinal                                         0    8   25   26   11 3 0              0    7 11 14 11     0   0
 Hematologic                                              0   13   16   13   20 11 0             0    9 8 8 10       8   0
 Hemorrhage                                               0   62    8    0    3 0 0              0   40 1 1 1        0   0
 Immunological                                            0   72    0    1    0 0 0              0   39 1 1 1        1   0
 Infection                                                1   55    3    6    7 0 1              0   35 0 2 6        0   0
 Liver                                                    0   49   15    7    2 0 0              0   27 13 0 2       1   0
 Lung                                                     3   23    9   15   17 5 1              0   13 1 9 16       2   2
 Metabolic                                                0   50    8    6    7 2 0              0   25 8 3 7        0   0
 Musculoskeletal                                          0   65    1    4    3 0 0              0   35 2 3 3        0   0
 Neurologic                                               1   33   22    9    7 1 0              0   20 9 8 5        0   1
 Pain                                                     0   29   18   15   10 1 0              0   20 9 11 2       1   0
 Renal/Bladder                                            1   60    9    3    0 0 0              0   34 4 5 0        0   0

 MAXIMUM GRADE ANY ADVERSE
 EVENT
 Number                                                   0    0    4 12 38 18 1                 0   1   2   4 22 11 3




APRIL 7 - 10, 2005                          SOUTHWEST ONCOLOGY GROUP                                         LUNG        27

                                                        S0027/II
                                                     S0119 Phase II
        Phase II Trial of Gemcitabine (NSC-613327)/Irinotecan (NSC-616348) in
          Patients with Untreated Extensive Small Cell Lung Cancer (SCLC)

     Study Coordinators:                                               Date Activated:
        W Akerley, P Hesketh                                              1/1/2002
     Statisticians:                                                    Date Closed:
         J McCoy, J Crowley                                                2/15/2003
     Data Coordinator:
        L Kaye



     Objectives                                                        Patients must not have received any prior chemo-
     To assess the survival of patients with extensive                 therapy, biologic or radiation therapy for small
     small cell lung cancer (SCLC) treated with gem-                   cell lung cancer. Prior surgery is allowed pro-
     citabine and irinotecan.                                          vided patients have recovered from all associated
     To assess the response rates (confirmed plus un-                  toxicities.
     confirmed, complete and partial) of patients with                 All patients must have a Zubrod performance
     extensive small cell lung cancer (SCLC) treated                   status of 0-2 with adequate hematologic and he-
     with gemcitabine and irinotecan.                                  patic function.
     To evaluate the side effects and overall toxicities               Accrual Goals
     associated with gemcitabine and irinotecan.                       The accrual goal is 75 eligible patients.
     Patient Population                                                Summary Statement
     Patients must have histologically or cytologically                This trial met its accrual goal and closed on Feb-
     confirmed diagnosis of extensive small cell lung                  ruary 15, 2003 with 85 patients registered. One
     cancer. There must be disease outside the area of                 patient is currently listed as ineligible.
     any previous surgical resection or a new lesion                   There have been at least five treatment-related
     must be present. Such disease must be docu-                       deaths. One patient died of a hemorrhage, one
     mented by CT, MRI, X-ray, nuclear exam or
                                                                       died of a cardiac infarction, one died of an embo-
     physical exam. Patients with brain metastases are                 lism, one died of cardiac arrhythmia and another
     only eligible if the brain metastases are controlled              died from hypotension; one other case is under
     (i.e., without symptoms or who have had their
                                                                       review for possibly treatment-related causes of
     metastases treated with radiation and/or surgery).                death. Additionally, thirteen patients have experi-
                                                                       enced Grade 4 toxicities.




28     LUNG                                    SOUTHWEST ONCOLOGY GROUP                                     APRIL 7 - 10, 2005

                                                            S0119/II
                                     Initial Registrations By 1 Month Intervals

               20




               10



                                                                   14

                                       11                                                            11

                                                            8                 8         8
                                                                                               7
                        5                    5
                                                                                                              4
                               3
                                                                                                                    1
                0
                       MAR    APR    MAY    JUN          JUL      AUG       SEP        OCT    NOV    DEC    JAN    FEB
                       2002   2002   2002   2002         2002     2002      2002       2002   2002   2002   2003   2003
                                                                Time of Registration
                                                                    Gemcitabine/CPT-11



                                             Registration by Institution
                                                 Total                                                                    Total
        Institutions                             Reg                    Institutions                                      Reg

        Ozarks Reg CCOP                            9                    St Francis/Stormont/Kansas, U of                   2
        Upstate Carolina                           8                    Virginia Mason CCOP                                2
        Southeast CCC CCOP                         7                    Akron Gen Med Ctr/Cleveland Clinic OH              1
        Wichita CCOP                               5                    Bay Area CCOP                                      1
        Cleveland Clinic OH                        4                    Bay Medical Center/Michigan, U of                  1
        Columbus CCOP                              4                    Berkshire Hem/Onc/Rochester, Univ of               1
        Greenville CCOP                            4                    Boston Univ Med Ctr                                1
        Henry Ford Hosp                            4                    Capital District Hem/Rochester, Univ of            1
        Central IL CCOP                            3                    Community Onc Grp/Cleveland Clinic OH              1
        Dayton CCOP                                3                    Grand Rapids CCOP                                  1
        Loyola University                          3                    Kansas, U of                                       1
        Montana CCOP                               3                    Oakwood Hospital/Michigan, U of                    1
        BAMC/WHMC                                  2                    Scott & White CCOP                                 1
        Davis, U of CA                             2                    So Calif, U of                                     1
        LSU-Shreveport                             2                    South Texas Onc/Hem/San Antonio, U of TX           1
        Rochester, Univ of                         2                    St Mary's Hospital/St Louis University             1
        St Elizabeth's MC/Davis, U of CA           2                    Total (33 Institutions)                           85


                                      Registration, Eligibility, and Evaluability
                                                   Data as of January 1, 2005
                                            Gemcitabine/                                                           Gemcitabine/
                                              CPT-11                                                                 CPT-11

      NUMBER REGISTERED                                85                   ADVERSE EVENT ASSESSMENT
        INELIGIBLE                                      1                     Evaluable                                        84
        ELIGIBLE                                       84

           RESPONSE ASSESSMENT
             Determinable                              59
             Not Determinable                          25




APRIL 7 - 10, 2005                               SOUTHWEST ONCOLOGY GROUP                                                         LUNG   29

                                                                   S0119/II
                                                           Patient Characteristics
                                                            Data as of January 1, 2005
                                          Gemcitabine/CPT-11                                              Gemcitabine/CPT-11
                                                (n=84)                                                          (n=84)
               AGE                                                        HISPANIC
                 Median                   64.3                              No                            84          100%
                 Minimum                  42.0
                 Maximum                  85.2                            RACE
                                                                            White                         73              87%
               SEX                                                          Black                          8              10%
                 Males                    39                46%             Asian                          1               1%
                 Females                  45                54%             Pacific Islander               1               1%
                                                                            Unknown                        1               1%


                                                           Treatment Summary
                                                            Data as of January 1, 2005
                                                                                               Gemcitabine/
                                                                                                 CPT-11

                                     NUMBER ON PROTOCOL TREATMENT                                     0
                                     NUMBER OFF PROTOCOL TREATMENT                                   84
                                       REASON OFF TREATMENT
                                         Treatment completed as planned                              28
                                         Adverse Events or side effects                               9
                                         Refusal unrelated to adverse events                          1
                                         Progression/relapse                                         34
                                         Death                                                        9
                                         Other - not protocol specified                               3

                                         Reason under review                                          0
                                     MAJOR PROTOCOL DEVIATIONS                                        0


                     Number of Patients with a Given Type and Grade of Adverse Event
                               Adverse Events Unlikely or Not Related to Treatment Excluded
                                               Data as of January 1, 2005
                           Gemcitabine/CPT-11                                                                         Gemcitabine/CPT-11
                                 (n=84)                                                                                     (n=84)

                                    Grade                                                                                       Grade
     ADVERSE EVENT         0    1     2        3   4   5                         ADVERSE EVENT                        0     1     2      3    4   5

 ADR                     83     0     0      0     0   1          Infection                                          70     0     4      8    2   0
 Cardiovascular          44    13    10     11     2   4          Liver                                              43    27    11      2    1   0
 Clotting                83     0     0      1     0   0          Lung                                               44     8    18     13    1   0
 Dermatologic            46    24    13      1     0   0          Metabolic                                          50    13     7     11    3   0
 Ear                     82     1     1      0     0   0          Musculoskeletal                                    66    11     4      3    0   0
 Endocrine               83     0     0      1     0   0          Neurologic                                         52    16     9      3    4   0
 Eye                     80     2     2      0     0   0          Pain                                               47    20    12      4    1   0
 Flu-like Symptoms       12    34    28      8     2   0          Renal/Bladder                                      73     6     3      2    0   0
 Gastrointestinal         9    29    26     18     2   0
 Hematologic             13    15    26     24     6   0          MAXIMUM GRADE ANY ADVERSE EVENT
 Hemorrhage              76     5     1      1     0   1          Number                                              0     3    21     41   13   6
 Immunological           81     3     0      0     0   0




30     LUNG                                            SOUTHWEST ONCOLOGY GROUP                                                 APRIL 7 - 10, 2005

                                                                      S0119/II
                                                  S0124 Phase III
                                           Coordinating Group: SWOG
     Randomized Phase III Trial of Cisplatin (NSC-119875) and Irinotecan
   (NSC-616348) versus Cisplatin and Etoposide (NSC-141540) in Patients with
                   Extensive Stage Small Cell Lung Cancer

   Participants:                                                      Date Activated:
       SWOG, CTSU (endorsed by CALGB and NCCTG)                          11/1/2002
   Study Coordinators:
       R Natale, P Lara, H Lenz, D Gandara
   Statisticians:
       J Crowley, K Chansky
   Data Coordinator:
      L Kaye




                                                          Schema

                                  R
                                  A
                                                  Cisplatin + Irinotecan
                                  N
                                  D
                                  O
                                  M
                                  I
                                  Z
                                  A
                                  T
                                  I
                                  O               Cisplatin + Etoposide
                                  N

   Objectives                                                         cisplatin and irinotecan and to cisplatin and eto-
   To compare the survival of patients with exten-                    poside.
   sive stage small cell lung cancer (E-SCLC)
                                                                      Patient Population
   treated with cisplatin and irinotecan versus cis-
                                                                      Patients must have histologically or cytologically
   platin and etoposide.                                              confirmed diagnosis of extensive small cell lung
   To compare the objective response rate, progres-                   carcinoma. They must have disease outside the
   sion-free survival and toxicities of patients with                 area of any previous surgical resection and/or ra-
   E-SCLC treated with cisplatin and irinotecan ver-                  diation field, or a new lesion must be present.
   sus cisplatin and etoposide.                                       Such disease must be documented by a CT, MRI,
   To assess the association between UGT1A1                           X-ray, physical exam or nuclear exam. Patients
                                                                      with brain metastases are eligible only if they
   polymorphisms and irinotecan-associated toxici-
   ties in patients with extensive small cell lung can-               have been treated with radiation and/or surgery.
   cer.                                                               Patients must not have received any prior radia-
                                                                      tion therapy (except for brain metastases), sys-
   To assess the association between ERCC-1 and
   XRCC-1 polymorphisms and non-response to                           temic chemotherapy or biologic therapy for small
                                                                      cell lung cancer.



APRIL 7 - 10, 2005                           SOUTHWEST ONCOLOGY GROUP                                           LUNG       31

                                                          S0124/III
     All patients must have a Zubrod performance                          Three patients never started treatment, a major
     status of 0 or 1. All patients must have adequate                    deviation, and are not evaluable for toxicity.
     hematologic, hepatic, and renal function. Institu-                   There have been at least five treatment-related
     tions must have IRB approval for S9925 in order                      deaths on the CPT-11 arm, one due to cere-
     to register patients on this trial.                                  brovascular ischemia and four due to respiratory
                                                                          infection with neutropenia; one other death within
     Stratification/Descriptive Factors
                                                                          30 days of treatment on the CPT-11 arm is under
     Patients will be stratified by LDH: ≤IULN vs
     >IULN.                                                               investigation for possibly treatment-related
                                                                          causes. In addition, of the 145 patients evaluable
     Accrual Goals                                                        for toxicity on the CPT-11 arm, 29 have experi-
     Six hundred and twenty eligible patients will be                     enced Grade 4 toxicity. There have been at least
     accrued to this study. An interim analysis will be                   four treatment-related deaths on the VP16 arm,
     performed after the first 310 eligible patients                      two due to flu-like symptoms, one due to leuko-
     have been entered. A second interim analysis will                    penia, pneumonia, febrile neutropenia, dyspnea
     be performed after 2/3 of the expected deaths                        and hypoxia and one due to renal failure and in-
     have occurred.                                                       fection with multiple hematologic disorders; one
     Summary Statement                                                    other death within 30 days of treatment on the
     As of December 31, 2004, 328 patients had been                       VP16 arm is under investigation for possibly
     accrued to the study, of whom twelve are cur-                        treatment-related causes. Seventy-three out of the
     rently listed as ineligible.                                         141 patients evaluable for toxicity on the VP16
                                                                          arm have experienced Grade 4 toxicity.


                                     Initial Registrations By 3 Month Intervals

                70



                60



                50                                                                               30


                                                                                        30
                40
                                                                                                           21
                                                                  22
                30                                                            17
                                            15
                                                       16
                20
                                                                                                 34
                                 9                                                      26                 25
                10                                                20          20
                                            17
                                                       13
                                 9
                       2
                       2
                 0
                      OCT       JAN        APR        JUL        OCT           JAN     APR       JUL      OCT
                      DEC       MAR        JUN        SEP        DEC          MAR      JUN       SEP      DEC
                      2002      2003       2003       2003       2003         2004     2004      2004     2004
                                                          Time of Registration
                                       CDDP/CPT-11                                   CDDP/VP16




32     LUNG                                       SOUTHWEST ONCOLOGY GROUP                                       APRIL 7 - 10, 2005

                                                             S0124/III
                                                   Registration by Institution
                                               Registrations ending December 31, 2004
                                                       Total                                                       Total
   Institutions                                        Reg             Institutions                                Reg

   CTSU                                               121              Southeast CCC CCOP                            5
   Columbus CCOP                                       16              Hem/Onc Associates/Utah, U of                 4
   Wichita CCOP                                        16              St Louis CCOP                                 4
   LSU-Shreveport                                       9              Thompson Ca Surv Ctr/San Antonio, U of TX     4
   Montana CCOP                                         9              Utah, U of                                    4
   Dayton CCOP                                          7              Central IL CCOP                               3
   Northwest CCOP                                       7              Davis, U of CA                                3
   Grand Rapids CCOP                                    6              Gulf Coast MBCCOP                             3
   Ozarks Reg CCOP                                      6              Henry Ford Hosp                               3
   SW Cancer & Res Ctr/San Antonio, U of TX             6              Rochester, Univ of                            3
   Upstate Carolina                                     6              St Francis/Stormont/Kansas, U of              3
   Boston Univ Med Ctr                                  5              Sutter Hlth Western/Davis, U of CA            3
   Greenville CCOP                                      5              All Other Institutions                       62
   Kansas, U of                                         5              Total (67 Institutions)                     328


                                        Registration, Eligibility, and Evaluability
                              Registrations ending December 31, 2004; Data as of February 7, 2005
                                                                                      CDDP/CPT-
                                                                  TOTAL                  11           CDDP/VP16

                     NUMBER REGISTERED                              328                  166              162
                       INELIGIBLE                                    12                    5                7
                       ELIG./ PEND. ELIG.                           316                  161              155
                         Analyzable, Pend. Elig.                     27                   15               12

                          RESPONSE ASSESSMENT
                            Determinable                            145                   69                76
                            Not Determinable                         57                   29                28
                            Too Early                               114                   63                51

                          ADVERSE EVENT ASSESSMENT
                            Evaluable                               286                  145              141
                            Not Evaluable                             3                    1                2
                            Too Early                                27                   15               12




APRIL 7 - 10, 2005                                 SOUTHWEST ONCOLOGY GROUP                                        LUNG    33

                                                               S0124/III
                                            Patient Characteristics
                      Registrations ending December 31, 2004; Data as of February 7, 2005
                                                  CDDP/CPT-11                CDDP/VP16
                                                    (n=161)                   (n=155)

                  AGE
                    Median                      63.7                    62.3
                    Minimum                     22.0                    38.1
                    Maximum                     83.1                    78.6

                  SEX
                    Males                       98          61%         87          56%
                    Females                     63          39%         68          44%

                  HISPANIC
                    Yes                          4           2%          1           1%
                    No                         157          98%        154          99%

                  RACE
                    White                      154          96%        145          94%
                    Black                        3           2%          9           6%
                    Asian                        1           1%          0           0%
                    Native American              1           1%          0           0%
                    Multi-Racial                 2           1%          0           0%
                    Unknown                      0           0%          1           1%

                  LDH
                    < = IULN                    61          38%         60          39%
                    > IULN                     100          62%         95          61%

                  METASTATIC SITES
                   Single                       45          28%         45          29%
                   Multiple                    116          72%        110          71%

                  WEIGHT LOSS
                   < = 5%                      105          65%         98          63%
                   > 5%                         56          35%         57          37%


                                             Treatment Summary
                      Registrations ending December 31, 2004; Data as of February 7, 2005
                                                                      CDDP/CPT-
                                                           TOTAL         11              CDDP/VP16

            NUMBER ON PROTOCOL TREATMENT                        76           43              33

            NUMBER OFF PROTOCOL TREATMENT                     240         118               122
              REASON OFF TREATMENT
                Treatment completed as planned                107            52              55
                Adverse Events or side effects                 38            21              17
                Refusal unrelated to adverse events             2             2               0
                Progression/relapse                            23            13              10
                Death                                           8             5               3
                Other - not protocol specified                 14             4              10

                Reason under review                             48           21              27
            MAJOR PROTOCOL DEVIATIONS                            3            1               2




34   LUNG                                 SOUTHWEST ONCOLOGY GROUP                                APRIL 7 - 10, 2005

                                                       S0124/III
                     Number of Patients with a Given Type and Grade of Adverse Event
                              Adverse Events Unlikely or Not Related to Treatment Excluded
                            Registrations ending December 31, 2004; Data as of February 7, 2005
                                                          CDDP/CPT-11                             CDDP/VP16
                                                            (n=145)                                (n=141)

                                                               Grade                                  Grade
              ADVERSE EVENT                        Unk     0    1      2    3    4   5   Unk      0    1      2    3    4   5

 ADR                                                 0   144    0      0    0    0   1     0   139     1    0      0    0   1
 Cardiovascular                                      0   105   12     11   13    3   1     0   106    13    9      8    4   1
 Clotting                                            0   142    2      0    1    0   0     0   139     2    0      0    0   0
 Dermatologic                                        0    82   35     28    0    0   0     1    48    16   74      1    1   0
 Ear                                                 0   136    2      6    1    0   0     0   120     7   12      2    0   0
 Endocrine                                           0   145    0      0    0    0   0     0   139     0    0      2    0   0
 Eye                                                 1   141    1      2    0    0   0     1   134     3    3      0    0   0
 Flu-like Symptoms                                   0    43   42     43   11    6   0     0    32    43   52     12    0   2
 Gastrointestinal                                    0    16   41     30   52    6   0     0    21    37   57     23    3   0
 Hematologic                                         0    31   25     31   35   23   0     0    13     7   15     35   69   2
 Hemorrhage                                          0   137    7      1    0    0   0     0   136     4    0      1    0   0
 Immunological                                       0   141    3      1    0    0   0     0   134     2    3      1    1   0
 Infection                                           0   110    2     10   19    0   4     2   101     1   13     16    6   2
 Liver                                               1    99   34     11    0    0   0     0    95    27   13      4    2   0
 Lung                                                3    90   10     29   12    1   0     1    92     9   27      6    5   1
 Metabolic                                           1    90   19     10   20    5   0     0    89    16   11     14   11   0
 Musculoskeletal                                     0   138    2      2    2    1   0     0   138     1    2      0    0   0
 Neurologic                                          0   101   27     10    7    0   0     0   102    18   16      4    1   0
 Pain                                                0    92   21     24    7    1   0     0    76    33   24      6    2   0
 Renal/Bladder                                       0   117   13      6    8    1   0     0   106    21    7      4    2   1
 Sexual/Reproductive Function                        0   145    0      0    0    0   0     0   140     0    1      0    0   0
 Syndromes                                           0   144    0      0    1    0   0     0   140     0    0      1    0   0

 MAXIMUM GRADE ANY ADVERSE EVENT
 Number                                              0     2   12     34   62   29   6     0      4    3   17     39   73   5




APRIL 7 - 10, 2005                            SOUTHWEST ONCOLOGY GROUP                                             LUNG     35

                                                          S0124/III
                                                   S0126 Phase II
      Phase II Trial of Chronic Oral ZD1839 (Iressa®)(NSC-715055) in Selected
               Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)

     Study Coordinators:                                             Date Activated:
        H West, W Franklin, P Gumerlock, D Lau, R Vance                 12/1/2001
     Statisticians:                                                  Date Closed:
         J McCoy, J Crowley, K Chansky                                   7/1/2003
     Data Coordinator:
        C White



     Objectives                                                      Prior biologic therapy, chemotherapy, radiother-
     To assess the one-year survival rate in both pre-               apy and surgery are allowed.
     viously-untreated and previously-treated patients               Patients must have adequate hepatic function and
     with advanced bronchioloalveolar carcinoma re-                  a Zubrod performance status of 0-2.
     ceiving chronic oral ZD1839.
                                                                     Within 28 days prior to registration, all patients
     To assess the progression-free survival and over-               must have a slit lamp examination with fluorescin
     all survival in these groups of patients.                       staining to: 1) evaluate visual acuity, 2) evert lid
     To evaluate the frequency and severity of toxici-               and quantify conjunctival hyperemia, and 3) pho-
     ties associated with this treatment regimen.                    tograph any eye abnormality when possible.
     To evaluate the response rate using both the stan-              Stratification/Descriptive Factors
     dard RECIST criteria and by computer-assisted                   At the time of registration, patients will be strati-
     image analysis in patients with measurable dis-                 fied by prior systemic therapy for BAC: yes vs
     ease.                                                           no.
     To measure EGFR and EGFR variant III overex-                    Accrual Goals
     pression in tumor tissues samples and explore                   Fifty-five eligible previously untreated patients
     their relationship with aforementioned clinical                 and thirty-five eligible previously treated patients
     outcomes.                                                       will be accrued to the study (90 patients total).
     To explore EGFR expression and activation                       Summary Statement
     status in slides of buccal brushings submitted on               This study accrued 145 patients, eight of whom
     S9925 before and after initiation of treatment                  are currently listed as ineligible. The previously-
     with ZD1839 to assess whether baseline measures                 treated stratum was closed on July 1, 2003 and
     or changes from baseline measures correlate with                the previously-untreated stratum was closed on
     response to therapy and survival.                               February 15, 2003 after accrual goal was reached
                                                                     for the respective strata.
     Patient Population
     Patients must have a biopsy-proven (bronchial                   One patient died prior to receiving any protocol
     brushings or washing not permitted), incom-                     treatment, and is not analyzable. There have been
     pletely resected or unresectable bronchioloalveo-               at least five treatment-related deaths among 136
     lar carcinoma. Patients must have either selected               evaluated patients. One patient died of ARDS,
     Stage IIIB disease due to cytology-confirmed ma-                one died due to CHF, one died of renal failure
     lignant pleural effusion, or Stage IV disease.                  and infection, and two died of cardiac infarction;
     There must be evidence of disease by CT scan;                   three other cases are under review for unknown,
     disease must be present outside of areas of previ-              but possibly treatment-related, causes of death.
     ous radiation therapy. Patients with brain metas-
     tases are ineligible.




36     LUNG                                   SOUTHWEST ONCOLOGY GROUP                                     APRIL 7 - 10, 2005

                                                          S0126/II
                                                   Registration by Institution
                                                     Total                                                            Total
        Institutions                                 Reg            Institutions                                      Reg

        Davis, U of CA                                18            Med City Dallas Hosp/San Antonio, U of TX           2
        Puget Sound                                    9            Michigan CRC CCOP                                   2
        Columbus CCOP                                  8            Mississippi, Univ of                                2
        Atlanta Reg CCOP                               7            NE Georgia Med Ctr/Mississippi, Univ of             2
        Scott & White CCOP                             6            New Mexico MBCCOP                                   2
        Southeast CCC CCOP                             6            So Calif, U of                                      2
        Wichita CCOP                                   6            St Elizabeth's MC/Davis, U of CA                    2
        Kansas, U of                                   5            St Joseph Hospital/Puget Sound                      2
        Sutter Hlth Western/Davis, U of CA             5            St Joseph Mercy/Henry Ford Hosp                     2
        City of Hope Med Ctr                           4            Utah, U of                                          2
        Grand Rapids CCOP                              4            Boston Univ Med Ctr                                 1
        Hawaii MBCCOP, U of                            4            Dixie Medical Center/Utah, U of                     1
        Ozarks Reg CCOP                                4            Henry Ford Hosp                                     1
        Rochester, Univ of                             4            Marquette Gen Hosp/Wayne State Univ                 1
        Upstate Carolina                               4            Montana CCOP                                        1
        Columbia River CCOP                            3            Mt Clemens Gen Hosp/Wayne State Univ                1
        Dayton CCOP                                    3            Providence Yakima MC/Puget Sound                    1
        Kaiser, Sacramento/Davis, U of CA              3            St Bernards Reg MC/Arkansas, U of                   1
        Wayne State Univ                               3            St Edward Mercy MC/Arkansas, U of                   1
        Colorado, U of                                 2            Wenatchee Valley/Puget Sound                        1
        Greenville CCOP                                2            Yakima Valley Mem/Puget Sound                       1
        Kansas City CCOP                               2            Total (44 Institutions)                           145
        Loyola University                              2


                                        Registration, Eligibility, and Evaluability
                                              Classified by Previous Systemic Therapy
                                                     Data as of January 1, 2005
                                                                                     Previously         Previously
                                                                   TOTAL             Untreated           Treated

                     NUMBER REGISTERED                               145                104                   41
                       INELIGIBLE                                      8                  3                    5
                       ELIGIBLE                                      137                101                   36
                         Analyzable, Pend. Elig.                       2                  1                    1
                         Not Analyzable                                1                  0                    1

                          BASELINE DISEASE STATUS
                            Measurable                                   96              72                   24
                            Non Measurable                               40              29                   11

                          RESPONSE ASSESSMENT
                            Determinable                             110                 83                   27
                            Not Determinable                          19                 14                    5
                            Too Early                                  7                  4                    3

                          ADVERSE EVENT ASSESSMENT
                            Evaluable                                136                101                   35


                                                     Patient Characteristics
                                                      Data as of January 1, 2005
                                     Oral ZD1839                                                             Oral ZD1839
                                       (n=136)                                                                 (n=136)
       AGE                                                   RACE
         Median                 68.0                           White                                   122            90%
         Minimum                34.3                           Black                                     7             5%
         Maximum                88.6                           Asian                                     6             4%
                                                               Unknown                                   1             1%
       SEX
         Males                  67             49%           PREVIOUS SYSTEMIC THERAPY
         Females                69             51%             Previously Untreated                    101            74%
                                                               Previously Treated                       35            26%
       HISPANIC
         Yes                     4              3%
         No                    132             97%




APRIL 7 - 10, 2005                                   SOUTHWEST ONCOLOGY GROUP                                               LUNG   37

                                                                S0126/II
                                                  Treatment Summary
                                          Classified by Previous Systemic Therapy
                                                 Data as of January 1, 2005
                                                                                         Previously    Previously
                                                                    TOTAL                Untreated      Treated

                 NUMBER ON PROTOCOL TREATMENT                              13                    9           4

                 NUMBER OFF PROTOCOL TREATMENT                          123                     92          31
                   REASON OFF TREATMENT
                     Adverse Events or side effects                        20                   15           5
                     Refusal unrelated to adverse events                    1                    1           0
                     Progression/relapse                                   65                   48          17
                     Death                                                 17                   12           5
                     Other - not protocol specified                        10                    8           2

                     Reason under review                                   10                    8           2
                 MAJOR PROTOCOL DEVIATIONS                                  0                    0           0


                  Number of Patients with a Given Type and Grade of Adverse Event
                                          Classified by Previous Systemic Therapy
                                Adverse Events Unlikely or Not Related to Treatment Excluded
                                                 Data as of January 1, 2005
                                                           Previously Untreated                       Previously Treated
                                                                 (n=101)                                    (n=35)

                                                                  Grade                                    Grade
              ADVERSE EVENT                                      Unk       0    1   2   3 4 5              Unk       0   1   2   3 4 5

 ADR                                                                0 98         0 0 0 0 3                       0   35 0 0      0   0   0
 Cardiovascular                                                     0 95         3 0 1 0 2                       1   31 1 0      0   1   1
 Clotting                                                           0 98         1 0 2 0 0                       0   34 0 0      1   0   0
 Dermatologic                                                       0   9       42 37 12 1 0                     0    9 8 15     3   0   0
 Eye                                                                0 82         9 8 2 0 0                       0   30 2 3      0   0   0
 Flu-like Symptoms                                                  0 55        24 18 4 0 0                      0   16 10 6     3   0   0
 Gastrointestinal                                                   0 19        35 20 25 2 0                     0   11 10 6     8   0   0
 Hematologic                                                        0 78        18 4 1 0 0                       0   27 4 4      0   0   0
 Hemorrhage                                                         0 95         5 0 1 0 0                       0   34 1 0      0   0   0
 Immunological                                                      0 92         7 2 0 0 0                       0   32 2 1      0   0   0
 Infection                                                          0 94         0 4 2 0 1                       0   34 0 1      0   0   0
 Liver                                                              0 69        21 6 5 0 0                       0   20 9 4      2   0   0
 Lung                                                               0 90         0 6 4 1 0                       0   29 1 1      3   0   1
 Metabolic                                                          0 93         4 1 3 0 0                       0   30 3 1      1   0   0
 Neurologic                                                         0 97         4 0 0 0 0                       0   33 2 0      0   0   0
 Pain                                                               0 92         7 1 1 0 0                       0   34 1 0      0   0   0
 Renal/Bladder                                                      0 87        11 0 2 0 1                       0   29 3 3      0   0   0
 Sexual/Reproductive Function                                       0 100        1 0 0 0 0                       0   35 0 0      0   0   0

 MAXIMUM GRADE ANY ADVERSE EVENT
 Number                                                             0      2 17 36 37 3 6                        0   2   4 12 14 1 2




38   LUNG                                      SOUTHWEST ONCOLOGY GROUP                                               APRIL 7 - 10, 2005

                                                                S0126/II
                                         S0220 Phase II Intergroup
                                          Coordinating Group: SWOG
     A Phase II Trial of Induction Chemoradiotherapy with Cispatin/Etoposide
     Followed by Surgical Resection, Followed by Docetaxel for Non-Small Cell
          Lung Cancer Involving the Superior Sulcus (Pancoast Tumors)

   Intergroup Participants:                                            Date Activated:
       SWOG, ECOG, NCCTG                                                  7/1/2003
   Study Coordinators:
       M Kraut, J Sonett, V Rusch, C Thomas, J Jett (NCCTG),
       H Gillenwater (ECOG)
   Statisticians:
       J McCoy, J Crowley
   Data Coordinator:
      L Kaye




                                                         Schema

     R                               Local or distant
                                                                     Off protocol treatment
     E                    R          progression
     G                    E
     I        CDDP        E
     S                    V
                +
     T                    A                                  R                                R
              VP-16
     R                    L                                  E                                E
     A          +         U                                                                       Docetaxel
                                                             G            Surgery             G
     T         XRT        A                                                                       X 3 cycles
     I                    T                                  2                                3
     O                    E          No distant mets
     N                               No local
                                                                                              R
                                     progression                                              E
                                                            Refuse or                         G   Docetaxel
                                                            medically unfit                       X 3 cycles
                                                            for surgery                       3

   Objectives                                                          To investigate in an exploratory manner the asso-
   To assess overall survival in patients with Pan-                    ciation of p27, TUBB-III and Map4 expression
   coast tumors without mediastinal or supraclavicu-                   levels with patient responses and outcomes.
   lar nodal involvement treated with cisplatin and
                                                                       Patient Population
   etoposide for two cycles, concurrent with a pro-
                                                                       Patients must have histologic or cytologic proof
   gram of continuous, fractionated chest radiation                    of a newly diagnosed non-small cell lung carci-
   followed by surgical resection and consolidation                    noma with involvement of the superior sulcus
   chemotherapy with docetaxel.
                                                                       (T3-4, N0-1). Disease must be documented by
   To assess time to progression, response (con-                       both a chest X-ray and a CT scan. Patients with
   firmed plus unconfirmed, complete plus partial                      mediastinal or supraclavicular nodal involvement
   during induction), resectability rates and toxicity                 (N2-3), two or more parenchymal lesions, or dis-
   in this patient population treated with this regi-                  tant metastases (including malignant pleural effu-
   men.                                                                sions) are ineligible.




APRIL 7 - 10, 2005                           SOUTHWEST ONCOLOGY GROUP                                            LUNG       39

                                                          S0220/II
     Mediastinal exploration is required to establish                          formance status of 2 must also meet additional
     eligibility. Patients must not have had prior thora-                      requirements regarding liver function and weight
     cotomy for purposes other than diagnosis or stag-                         loss.
     ing. Patients must not have had any prior chemo-
                                                                               Accrual Goals
     therapy or radiotherapy for lung cancer.                                  This study will accrue 144 eligible patients.
     All patients must have adequate hematologic, he-
                                                                               Summary Statement
     patic, renal, cardiac, and pulmonary function, and
                                                                               This study opened to accrual on July 1, 2003. As
     they must be a candidate for potential future pul-
                                                                               of December 31, 2004, six patients have been ac-
     monary resection as determined by the attending
                                                                               crued to this study. Three patients have proceeded
     thoracic surgeon. Patients with clinical hearing
                                                                               to the surgery step and two patients have been
     loss must be willing to accept the potential for
                                                                               registered to the docetaxel step.
     worsening of symptoms. Patients with sympto-
     matic peripheral neuropathy, pericardial effu-                            There has been one treatment related death on the
     sions, or superior vena cava syndrome are ineli-                          induction step due to infection, among the four
     gible. All patients must have a Zubrod perform-                           patients evaluable for toxicity.
     ance status of 0, 1 or 2; those patients with a per-


                                                    Registration by Institution
                                                 Registrations ending December 31, 2004
                                                                                  Total
                                                   Institutions                   Reg

                                                   Montana CCOP                    2
                                                   Loyola University               1
                                                   New Mexico MBCCOP               1
                                                   Puget Sound                     1
                                                   Southeast CCC CCOP              1
                                                   Total (5 Institutions)          6


                                          Registration, Eligibility, and Evaluability
                             Registrations ending December 31, 2004; Data as of January 31, 2005
                                                       CDDP,                                                      CDDP,
                                                      VP-16/RT                                                   VP-16/RT

            NUMBER REGISTERED                              6                ADVERSE EVENT ASSESSMENT
              ELIG./ PEND. ELIG.                           6                  Evaluable                               4
                Analyzable, Pend. Elig.                    2                  Too Early                               2

                 RESPONSE ASSESSMENT
                   Determinable                            4
                   Too Early                               2


                                                      Patient Characteristics
                             Registrations ending December 31, 2004; Data as of January 31, 2005
                                          CDDP, VP-16/RT                                          CDDP, VP-16/RT
                                              (n=6)                                                   (n=6)
                AGE                                                   HISPANIC
                  Median                  68.0                          No                        6           100%
                  Minimum                 51.1
                  Maximum                 73.0                        RACE
                                                                        White                     5            83%
                SEX                                                     Native American           1            17%
                  Males                    4           67%
                  Females                  2           33%




40     LUNG                                          SOUTHWEST ONCOLOGY GROUP                                        APRIL 7 - 10, 2005

                                                                   S0220/II
                                                 Treatment Summary
                           Registrations ending December 31, 2004; Data as of January 31, 2005
                                                                                   CDDP,
                                                                                  VP-16/RT

                                   NUMBER ON PROTOCOL TREATMENT                       1

                                   NUMBER OFF PROTOCOL TREATMENT                      5
                                     REASON OFF TREATMENT
                                       Treatment completed as planned                 3
                                       Adverse Events or side effects                 0
                                       Refusal unrelated to adverse events            0
                                       Progression/relapse                            1
                                       Death                                          0
                                       Other - not protocol specified                 0

                                       Reason under review                            1
                                   MAJOR PROTOCOL DEVIATIONS                          0


                     Number of Patients with a Given Type and Grade of Adverse Event
                             Adverse Events Unlikely or Not Related to Treatment Excluded
                           Registrations ending December 31, 2004; Data as of January 31, 2005
                               CDDP, VP-16/RT                                                       CDDP, VP-16/RT
                                   (n=4)                                                                (n=4)

                                   Grade                                                                Grade
  ADVERSE EVENT          Unk   0   1   2    3     4   5               ADVERSE EVENT           Unk   0   1   2   3    4   5

 Alkaline phosphatase      0   3   1   0    0     0   0        Mucositis, clin: esophagus       0   3   0   0   1    0   0
 Constipation              0   3   1   0    0     0   0        Nausea                           0   2   2   0   0    0   0
 Dehydration               0   3   0   0    0     1   0        Neutrophils                      0   1   0   3   0    0   0
 Dizziness                 0   3   1   0    0     0   0        Pain-other                       0   3   0   1   0    0   0
 Esophagitis               1   3   0   0    0     0   0        Platelets                        0   2   2   0   0    0   0
 Fatigue                   0   3   1   0    0     0   0        Prolapse stoma, GI               0   3   1   0   0    0   0
 Febrile neutropenia       0   3   0   0    1     0   0        RT Dermatitis: RT dermatitis     0   3   0   1   0    0   0
 GU Pain: bladder          0   3   1   0    0     0   0        Taste alteration                 0   3   1   0   0    0   0
 Hemoglobin                0   2   1   1    0     0   0        Vomiting                         0   3   0   0   1    0   0
 Hyperglycemia             0   3   1   0    0     0   0        Weight Loss                      0   3   1   0   0    0   0
 Hypoalbuminemia           0   3   1   0    0     0   0
 Hypotension               0   3   1   0    0     0   0        MAXIMUM GRADE
 Inf, 3-4 ANC: blood       0   3   0   0    0     0   1          ANY ADVERSE EVENT
 Leukocytes                0   0   0   2    1     1   0        Number                           0   0   0   1   2    0   1




APRIL 7 - 10, 2005                              SOUTHWEST ONCOLOGY GROUP                                         LUNG    41

                                                           S0220/II
                                                     S0222 Phase II
       A Phase II Study of Tirapazamine (NSC-130181)/Cisplatin/Etoposide and
        Concurrent Thoracic Radiotherapy for Limited Stage Small Cell Lung
                                      Cancer

     Study Coordinators:                                                Date Activated:
        Q Le, S Williamson, P Lara, Z Goldberg                             9/1/2003
     Statisticians:
         J McCoy, J Crowley
     Data Coordinator:
        C White



     Objectives                                                         Patients must not have had prior chemotherapy,
     To assess overall survival in patients with limited                radiotherapy or biologic therapy for small cell
     stage small cell lung cancer (SCLC) treated with                   lung cancer.
     induction tirapazamine combined with cisplatin,                    Patients must have adequate hematologic, he-
     etoposide and high dose thoracic radiotherapy                      patic, and renal function and a Zubrod perform-
     followed by consolidative cisplatin and etoposide.                 ance status of 0 or 1. Patients with significant
     To assess time to treatment failure calculated                     clinical hearing loss must be willing to accept the
     from initiation of step 1, response (confirmed                     potential for worsening of symptoms. Patients
     plus unconfirmed, complete plus partial during                     must not have Grade 1 or greater symptomatic
     induction) in the subset of patients with measur-                  sensory neuropathy.
     able disease and toxicity in this patient population
                                                                        Accrual Goals
     treated with this regimen.
                                                                        The study will accrue 85 eligible patients.
     To investigate in an exploratory manner the asso-
                                                                        Summary Statement
     ciation of baseline PAI-1, VEGF, OPN and
                                                                        This study opened to accrual on September 1,
     NDRG1 plasma markers with patient response                         2003. As of December 31, 2004, twenty-seven
     and survival.
                                                                        patients have been accrued to the study, of whom
     Patient Population                                                 one is currently listed as ineligible. One patient
     Patients must have histologically or cytologically                 never received any protocol treatment and is not
     confirmed limited small cell lung carcinoma. Di-                   analyzable. Eight patients have experienced a
     agnosis on the basis of sputum cytology is ac-                     Grade 4 adverse event among the 15 patients
     ceptable if confirmation by an independent patho-                  evaluable for toxicity.
     logic review is documented. Patients with malig-                   Ten patients have gone on to the consolidation
     nant pleural or pericardial effusions are ineligible.              step. Two patients have experienced a Grade 4
                                                                        adverse event among the six patients evaluable
                                                                        for toxicity.




42     LUNG                                     SOUTHWEST ONCOLOGY GROUP                                     APRIL 7 - 10, 2005

                                                             S0222/II
                                                   Registration by Institution
                                                            Initial Registration
                                                Registrations ending December 31, 2004
                                                      Total                                                            Total
      Institutions                                    Reg               Institutions                                   Reg

      Columbus CCOP                                     4               Dayton CCOP                                     1
      Montana CCOP                                      3               LSU-Shreveport                                  1
      Northwest CCOP                                    3               Mt Clemens Gen Hosp/Wayne State Univ            1
      Gulf Coast MBCCOP                                 2               Ozarks Reg CCOP                                 1
      Loyola University                                 2               St Francis/Stormont/Kansas, U of                1
      Southeast CCC CCOP                                2               St Mary's Hospital/St Louis University          1
      Wichita CCOP                                      2               SW Cancer & Res Ctr/San Antonio, U of TX        1
      Adirondack Ca Care/Rochester, Univ of             1               Total (16 Institutions)                        27
      City of Hope Med Ctr                              1


                                        Registration, Eligibility, and Evaluability
                                                            Initial Registration
                                 Registrations ending December 31, 2004; Data as of January 1, 2005
                                                  PE/XRT + TPZ                                                     PE/XRT + TPZ

   NUMBER REGISTERED                                        27               RESPONSE ASSESSMENT
     INELIGIBLE                                              1                 Determinable                                  5
     ELIG./ PEND. ELIG.                                     26                 Not Determinable                              2
       Analyzable, Pend. Elig.                               8                 Too Early                                    18
       Not Analyzable                                        1
                                                                             ADVERSE EVENT ASSESSMENT
        BASELINE DISEASE STATUS                                                Evaluable                                    15
          Measurable                                        18                 Too Early                                    10
          Too Early                                          7


                                                     Patient Characteristics
                                                            Initial Registration
                                 Registrations ending December 31, 2004; Data as of January 1, 2005
                                              PE/XRT + TPZ                                        PE/XRT + TPZ
                                                  (n=25)                                              (n=25)
                     AGE                                                HISPANIC
                       Median              62.0                           No                 25            100%
                       Minimum             47.2
                       Maximum             77.4                         RACE
                                                                          White              25            100%
                     SEX
                       Males               10               40%
                       Females             15               60%




APRIL 7 - 10, 2005                                  SOUTHWEST ONCOLOGY GROUP                                                LUNG   43

                                                                  S0222/II
                                                           Treatment Summary
                                                               Initial Registration
                               Registrations ending December 31, 2004; Data as of January 1, 2005
                                                                                        PE/XRT + TPZ

                                      NUMBER ON PROTOCOL TREATMENT                                   9
                                      NUMBER OFF PROTOCOL TREATMENT                              16
                                        REASON OFF TREATMENT
                                          Treatment completed as planned                             3
                                          Adverse Events or side effects                             5
                                          Refusal unrelated to adverse events                        0
                                          Progression/relapse                                        0
                                          Death                                                      0
                                          Other - not protocol specified                             2

                                          Reason under review                                        6
                                      MAJOR PROTOCOL DEVIATIONS                                      0


                    Number of Patients with a Given Type and Grade of Adverse Event
                                                       Initial Registration
                                 Adverse Events Unlikely or Not Related to Treatment Excluded
                               Registrations ending December 31, 2004; Data as of January 1, 2005
                                   PE/XRT + TPZ                                                           PE/XRT + TPZ
                                       (n=15)                                                                 (n=15)

                                           Grade                                                                  Grade
     ADVERSE EVENT                0    1     2     3   4   5                     ADVERSE EVENT            0   1     2     3   4   5

 ALT                             11    1     2     1   0   0        Hypokalemia                          14   0     0     1   0   0
 AST                             12    1     2     0   0   0        Hypomagnesemia                       12   3     0     0   0   0
 Alkaline phosphatase            12    3     0     0   0   0        Hyponatremia                         14   0     0     1   0   0
 Alopecia                         5    4     6     0   0   0        Hypophosphatemia                     14   1     0     0   0   0
 Anorexia                        13    0     1     1   0   0        Hypotension                          11   0     3     1   0   0
 Bilirubin                       14    0     1     0   0   0        Leukocytes                            4   0     3     5   3   0
 Blurred vision                  14    1     0     0   0   0        Metabolic/Lab-other                  14   1     0     0   0   0
 Cardiac ischemia/infarction     14    0     0     0   1   0        Mucositis, clin: esophagus           14   0     0     1   0   0
 Constipation                     8    3     3     1   0   0        Mucositis, clin: oral cavity         14   1     0     0   0   0
 Creatinine                      13    2     0     0   0   0        Mucositis, funct: oral cav.          13   2     0     0   0   0
 Dehydration                      6    0     3     6   0   0        Mucositis, funct: pharynx            14   0     1     0   0   0
 Diarrhea                         8    5     1     1   0   0        Musc Inf, 0-2 ANC: soft tiss.        14   0     0     1   0   0
 Dysphagia                       10    0     3     2   0   0        Musculo. Pain: muscle                 9   0     1     5   0   0
 Dyspnea                         14    0     1     0   0   0        Nausea                                7   3     5     0   0   0
 Esophagitis                      7    1     4     3   0   0        Neurology-other                      14   0     0     1   0   0
 Fatigue                          4    3     7     1   0   0        Neuropathy-sensory                   14   0     1     0   0   0
 Febrile neutropenia             14    0     0     1   0   0        Neutrophils                           4   0     2     3   6   0
 GI Pain: abdomen                14    0     0     0   1   0        Ocular-other                         14   1     0     0   0   0
 GI-other                        14    0     1     0   0   0        Pain: NOS                            14   0     0     1   0   0
 GU Inf, 0-2 ANC: UTI            14    0     1     0   0   0        Platelets                             6   6     0     2   1   0
 Heartburn                       14    1     0     0   0   0        RT Dermatitis: RT dermatitis         12   2     1     0   0   0
 Hemoglobin                       7    3     4     1   0   0        Supra Arrhyth: Sinus Tachy.          14   0     1     0   0   0
 Hiccoughs                       14    0     0     1   0   0        Taste alteration                     11   2     2     0   0   0
 Hyperglycemia                   13    1     1     0   0   0        Thrombosis/embolism (vasc acc)       14   0     0     0   1   0
 Hyperkalemia                    14    0     1     0   0   0        Vomiting                             11   1     2     1   0   0
 Hypernatremia                   13    2     0     0   0   0        Weight Loss                           9   3     3     0   0   0
 Hypoalbuminemia                 13    1     1     0   0   0
 Hypocalcemia                    12    2     1     0   0   0        MAXIMUM GRADE ANY ADVERSE EVENT
 Hypoglycemia                    14    1     0     0   0   0        Number                                0   0     1     6   8   0




44    LUNG                                             SOUTHWEST ONCOLOGY GROUP                               APRIL 7 - 10, 2005

                                                                     S0222/II
                                          Registration, Eligibility, and Evaluability
                                                               Consolidation Therapy
                               Registrations ending December 31, 2004; Data as of January 1, 2005
                                                    Cisplatin/                                                      Cisplatin/
                                                    Etoposide                                                       Etoposide
                                                      (PE)                                                            (PE)

           NUMBER REGISTERED                              10                 ADVERSE EVENT ASSESSMENT
             ELIG./ PEND. ELIG.                           10                   Evaluable                                  6
               Analyzable, Pend. Elig.                     6                   Too Early                                  4


                                                          Treatment Summary
                                                               Consolidation Therapy
                               Registrations ending December 31, 2004; Data as of January 1, 2005
                                                                                                  Cisplatin/
                                                                                                  Etoposide
                                                                                                    (PE)

                                         NUMBER ON PROTOCOL TREATMENT                                  8

                                         NUMBER OFF PROTOCOL TREATMENT                                 2
                                           REASON OFF TREATMENT
                                             Treatment completed as planned                            1
                                             Adverse Events or side effects                            0
                                             Refusal unrelated to adverse events                       0
                                             Progression/relapse                                       0
                                             Death                                                     0
                                             Other - not protocol specified                            0

                                             Reason under review                                       1
                                         MAJOR PROTOCOL DEVIATIONS                                     0


                       Number of Patients with a Given Type and Grade of Adverse Event
                                                     Consolidation Therapy
                                 Adverse Events Unlikely or Not Related to Treatment Excluded
                               Registrations ending December 31, 2004; Data as of January 1, 2005
                          Cisplatin/Etoposide (PE)                                                             Cisplatin/Etoposide (PE)
                                    (n=6)                                                                                (n=6)

                                    Grade                                                                                 Grade
  ADVERSE EVENT            0    1    2      3   4     5                           ADVERSE EVENT                 0     1    2      3   4   5

 Alopecia                  3    1    2      0   0     0            Mucositis, clin: oral cavity                 5     0    0      1   0   0
 Constipation              5    1    0      0   0     0            Nausea                                       4     1    1      0   0   0
 Dehydration               4    0    0      2   0     0            Neuropathy-sensory                           4     2    0      0   0   0
 Dysphagia                 3    1    2      0   0     0            Neutrophils                                  2     0    2      0   2   0
 Esophagitis               4    1    1      0   0     0            Platelets                                    3     1    0      1   1   0
 Fatigue                   2    2    1      1   0     0            Vomiting                                     4     2    0      0   0   0
 Febrile neutropenia       5    0    0      1   0     0            Weight Loss                                  5     1    0      0   0   0
 Hemoglobin                1    2    2      1   0     0
 Hyperglycemia             5    1    0      0   0     0            MAXIMUM GRADE ANY ADVERSE EVENT
 Leukocytes                1    0    3      1   1     0            Number                                       0     0    4      0   2   0




APRIL 7 - 10, 2005                                    SOUTHWEST ONCOLOGY GROUP                                                    LUNG    45

                                                                       S0222/II
                                                   S0229 Ancillary
       A Randomized Trial Assessing the Effects of Exercise On Patients With
     Locally Advanced Non-Small Cell Lung Cancer Undergoing Curative Intent
                 Combined Modality Therapy (Ancillary to S0023)

     Study Coordinators:                                             Date Activated:
        A Wozniak, C Gotay, A Schwartz, K Albain, K Kelly,              9/1/2004
        R Chaplen
     Statisticians:
         K Chansky, J Crowley
     Data Coordinator:
        C White




                                                           Schema

                                 R
                                 A               12 week exercise program + education
                                 N
                                 D
                                 O
                                 M
                                 I
                                 Z               Education
                                 E

     Objectives                                                      ease, recent myocardial infarction, uncontrolled
     To assess the impact of a supervised exercise                   diabetes, or any other condition that would pre-
     program on patients receiving combined modality                 clude the patient from participating. Patients must
     therapy on S0023 for inoperable locally advanced                not have chemotherapy-induced neuropathy of
     non-small cell lung cancer with regard to exercise              Grade 3 or greater. The results of pulmonary
     tolerance as a measure of improved physiological                function tests performed within 28 days of ran-
     function.                                                       domization must be available.
     To assess the health-related quality of life of                 Stratification/Descriptive Factors
     these patients with regard to their multidimen-                 Patient randomization will be stratified by (1)
     sional functioning and perception of respiratory                S0023 treatment arm: ZD1839 vs placebo; (2)
     difficulties.                                                   performance status: 0-1 vs 2; (3) FEV1: ≥ 70%
                                                                     predicted study-related vs < 70% predicted study-
     Patient Population
                                                                     related; (4) smoking status: never vs former vs
     Patients must be registered and eligible for
                                                                     current.
     S0023, and must have been restaged following
     S0023 consolidation therapy. Patients must be                   Accrual Goals
     willing to participate in the 12 week exercise pro-             This trial will accrue 164 patients, 82 per arm.
     gram if they are randomized to that arm of the
                                                                     Summary Statement
     study.
                                                                     This study opened for accrual on September 1,
     Patients must have a Zubrod performance status                  2004. As of December 31, 2004, there have been
     of 0-2 and be without uncontrolled cardiac dis-                 no registrations.




46     LUNG                                    SOUTHWEST ONCOLOGY GROUP                                   APRIL 7 - 10, 2005

                                                             S0229
                                                      S0310 Phase II
        Phase II Trial of CG8123, an Autologous Cancer Vaccine (GVAX), in
       Patients with Selected Stage IIIB and IV Bronchioloalveolar Carcinoma
                                        (BAC)

   Study Coordinators:                                                Date Activated:
      A Davies, P Roberts, D Gandara, W Franklin, D Lau                  3/1/2004
   Statisticians:
       J McCoy, J Crowley
   Data Coordinator:
      C White



   Objectives                                                         tients must not be receiving immunosuppressants
   To assess overall survival in patients with ad-                    or treatment with systemic corticosteroids.
   vanced bronchioloalveolar carcinoma treated with                   Patients must have adequate hepatic, cardiac and
   CG8123 separately in patients with or without                      pulmonary function and a Zubrod performance
   prior systemic therapy for BAC.                                    status of 0-1. Patients must not have impending
   To evaluate progression-free survival, response                    spinal cord compression or evidence of pericar-
   rate (confirmed plus unconfirmed, complete plus                    dial tamponade. Patients must not have active
   partial) using both standard RECIST criteria and                   immune or autoimmune disease or be hypersensi-
   by computer assisted image analysis, and the fre-                  tive to any components of the vaccine or CG6444
   quency and severity of toxicities in this patient                  adenoviral vector.
   population treated with this regimen separately
                                                                      Stratification/Descriptive Factors
   based on prior systemic therapy.
                                                                      At the time of registration, patients will be strati-
   To evaluate patient report of functional status.                   fied by (1) prior systemic therapy for BAC: yes
   To determine the systemic biologic activity                        vs no and (2) pattern of BAC: diffuse vs. nodular.
   through evaluation of antigen-specific antitumor                   Accrual Goals
   and systemic cytokine responses generated to                       Sixty-seven eligible previously untreated patients
   vaccination with CG8123 and correlate with                         and fifty eligible previously treated patients will
   clinical outcome.                                                  be accrued to the study (117 patients total).
   Patient Population                                                 Summary Statement
   Patients must have clinically suspicious or bi-                    This study opened to accrual on March 3, 2004.
   opsy-proven bronchioloalveolar carcinoma and                       As of December 31, 2004, eleven patients have
   must not be candidates for curative resection. Pa-                 been registered. One patient on the tumor pro-
   tients must have either selected Stage IIIB disease                curement step was not assessed for toxicity and is
   due to malignant pleural effusion, or Stage IV                     not evaluable for adverse event assessment. There
   disease. There must be evidence of disease by CT                   have been no adverse events greater than Grade 2
   scan; disease must be accessible for tumor har-                    among the four patients evaluable for toxicity on
   vest via thoracentesis or a surgical procedure. Pa-                the tumor procurement step.
   tients with symptomatic and/or untreated brain
                                                                      Seven patients have proceeded to the vaccine
   metastases are not eligible.
                                                                      therapy step.
   Patients with prior biologic therapy, chemother-
   apy, radiotherapy and surgery are allowed. Pa-




APRIL 7 - 10, 2005                            SOUTHWEST ONCOLOGY GROUP                                            LUNG        47

                                                           S0310/II
                                       Registration by Institution
                                               Initial Registration
                                    Registrations ending December 31, 2004
                                                                         Total
                            Institutions                                 Reg

                            Davis, U of CA                                   6
                            Tulane University                                4
                            Arlington Cancer Ctr/San Antonio, U of TX        1
                            Total (3 Institutions)                          11


                           Registration, Eligibility, and Evaluability
                                     Classified by Prior Systemic Therapy
                                              Initial Registration
                  Registrations ending December 31, 2004; Data as of February 8, 2005
                                                                          Prior         No prior
                                                                        systemic        systemic
                                                            TOTAL       therapy         therapy

            NUMBER REGISTERED                                     11        8              3
              ELIGIBLE                                            11        8              3
                Analyzable, Pend. Elig.                            2        2              0

                 ADVERSE EVENT ASSESSMENT
                   Evaluable                                       4        2              2
                   Not Evaluable                                   1        1              0
                   Too Early                                       6        5              1


                                           Patient Characteristics
                                     Classified by Prior Systemic Therapy
                                              Initial Registration
                  Registrations ending December 31, 2004; Data as of February 8, 2005
                                             Prior systemic therapy     No prior systemic therapy
                                                      (n=8)                       (n=3)

            AGE
              Median                         65.5                           59.4
              Minimum                        40.1                           58.0
              Maximum                        71.4                           61.7

            SEX
              Males                            4             50%             0            0%
              Females                          4             50%             3          100%

            HISPANIC
              No                               8            100%             3          100%

            RACE
              White                            8            100%             3          100%

            BAC SUBGROUP
              Diffuse pattern BAC              1             13%             0            0%
              Nodular pattern BAC              7             88%             3          100%




48   LUNG                                 SOUTHWEST ONCOLOGY GROUP                                  APRIL 7 - 10, 2005

                                                       S0310/II
                                                     Treatment Summary
                                              Classified by Prior Systemic Therapy
                                                       Initial Registration
                           Registrations ending December 31, 2004; Data as of February 8, 2005
                                                                                     Prior     No prior
                                                                                   systemic    systemic
                                                                      TOTAL        therapy     therapy

                     NUMBER ON PROTOCOL TREATMENT                             0          0           0

                     NUMBER OFF PROTOCOL TREATMENT                        11             8           3
                       REASON OFF TREATMENT
                         Treatment completed as planned                       6          4           2
                         Adverse Events or side effects                       0          0           0
                         Refusal unrelated to adverse events                  0          0           0
                         Progression/relapse                                  0          0           0
                         Death                                                1          1           0
                         Other - not protocol specified                       0          0           0

                         Reason under review                                  4          3           1
                     MAJOR PROTOCOL DEVIATIONS                                0          0           0


                                     Registration, Eligibility, and Evaluability
                                              Classified by Prior Systemic Therapy
                                                     Vaccine Administration
                           Registrations ending December 31, 2004; Data as of February 8, 2005
                                                                                    Prior     No prior
                                                                                  systemic    systemic
                                                                    TOTAL         therapy     therapy

                      NUMBER REGISTERED                                   7          5           2
                        ELIG./ PEND. ELIG.                                7          5           2
                          Analyzable, Pend. Elig.                         6          4           2

                           BASELINE DISEASE STATUS
                             Measurable                                   2          2           0
                             Non Measurable                               1          1           0
                             Too Early                                    4          2           2

                           RESPONSE ASSESSMENT
                             Too Early                                    7          5           2

                           ADVERSE EVENT ASSESSMENT
                             Evaluable                                    1          0           1
                             Too Early                                    6          5           1




APRIL 7 - 10, 2005                                  SOUTHWEST ONCOLOGY GROUP                              LUNG   49

                                                               S0310/II
                                         Treatment Summary
                                   Classified by Prior Systemic Therapy
                                          Vaccine Administration
                  Registrations ending December 31, 2004; Data as of February 8, 2005
                                                                        Prior     No prior
                                                                      systemic    systemic
                                                             TOTAL    therapy     therapy

            NUMBER ON PROTOCOL TREATMENT                         6        5             1

            NUMBER OFF PROTOCOL TREATMENT                        1        0             1
              REASON OFF TREATMENT
                Treatment completed as planned                   0        0             0
                Adverse Events or side effects                   0        0             0
                Refusal unrelated to adverse events              0        0             0
                Progression/relapse                              0        0             0
                Death                                            0        0             0
                Other - not protocol specified                   0        0             0

                Reason under review                              1        0             1
            MAJOR PROTOCOL DEVIATIONS                            0        0             0




50   LUNG                             SOUTHWEST ONCOLOGY GROUP                               APRIL 7 - 10, 2005

                                                      S0310/II
                                                   S0327 Phase II
    A Phase II Trial of PS-341(NSC-681239) in Patients With Platinum-Treated
                      Extensive Stage Small Cell Lung Cancer

   Study Coordinators:                                               Date Activated:
      P Lara, A Davies                                                  9/1/2003
   Statisticians:                                                    Date Closed:
       K Chansky, J Crowley                                              8/1/2004
   Data Coordinator:
      L Kaye



   Objectives                                                        Stratification/Descriptive Factors
   To evaluate the efficacy of PS-341 in previously-                 Patients will be stratified by platinum sensitivity
   treated    platinum-sensitive    and    platinum-                 status: platinum-sensitive vs platinum-resistant or
   refractory patients with measurable disease and                   refractory.
   extensive stage small cell lung cancer (SCLC) in
                                                                     Accrual Goals
   terms of response rate (confirmed and uncon-
                                                                     There will be two stages of accrual. In each stra-
   firmed, complete and partial).
                                                                     tum, if at least one response is seen in the first 20
   To assess the qualitative and quantitative toxici-                eligible patients, then 20 additional patients will
   ties of PS-341 in this patient cohort.                            be accrued.
   To assess overall survival from registration in this              Summary Statement
   group of patients treated with PS-341.                            This study opened for accrual on September 1,
   To collect specimens via the Lung Cancer                          2003. The platinum-refractory stratum completed
   Specimen Repository Protocol (S9925) in order                     the first stage of accrual and was closed on June
   to perform exploratory analyses of the relation-                  1, 2004 with 30 patients. The platinum-sensitive
   ship between selected markers and patient out-                    stratum completed the first stage of accrual and
   comes.                                                            was closed on August 1, 2004, also with 30 pa-
                                                                     tients.
   Patient Population
   Patients must have histologically or cytologically                Three patients did not receive any protocol treat-
   confirmed diagnosis of extensive small cell lung                  ment and are not analyzable. One patient on the
   cancer, with measurable disease at study entry.                   platinum-sensitive stratum had their dose esca-
   Patients must have received a previous platinum-                  lated following a dose reduction due to toxicity, a
   based regimen, with failure to respond or re-                     major deviation. Out of the 28 patients evaluated
   sponse followed by progression. Patients with                     for toxicity in the platinum-sensitive stratum,
   brain metastases are eligible provided they are                   there have been three patients with Grade 4 tox-
   without symptoms and are not receiving either                     icities and no treatment-related deaths. There
   enzyme-inducing anticonvulsants or corticoster-                   have been two treatment-related deaths in the
   oid therapy to control symptoms. Prior biologic                   platinum-refractory stratum out of the 27 patients
   therapy, radiation therapy and surgery are al-                    evaluable for toxicity assessment. One patient
   lowed. There must be measurable disease outside                   died due to infection and another died due to
   the area of any previous surgical resection or ra-                dyspnea. Three additional patients on the plati-
   diotherapy, or a new measurable lesion must be                    num-refractory stratum experienced Grade 4 tox-
   present.                                                          icity.

   All patients must have a Zubrod performance                       Upon review of the toxicity, response and sur-
   status of 0-1 with adequate hematologic and renal                 vival data, this study will not be re-opened for
   function.                                                         further accrual.




APRIL 7 - 10, 2005                            SOUTHWEST ONCOLOGY GROUP                                           LUNG        51

                                                          S0327/II
                                           Registration by Institution
                                           Total                                                      Total
            Institutions                   Reg             Institutions                               Reg

            Central IL CCOP                 7              Augusta Onc Assoc/BAMC/WHMC                  1
            Davis, U of CA                  6              Dayton CCOP                                  1
            Southeast CCC CCOP              5              Kansas, U of                                 1
            Columbia River CCOP             4              MD Anderson                                  1
            Wichita CCOP                    4              Michigan, U of                               1
            Columbus CCOP                   3              Montana CCOP                                 1
            Grand Rapids CCOP               3              Ozarks Reg CCOP                              1
            Greenville CCOP                 3              Providence Yakima MC/Puget Sound             1
            St Louis CCOP                   3              Scott & White CCOP                           1
            City of Hope Med Ctr            2              So Calif, U of                               1
            Colorado, U of                  2              Upstate Carolina                             1
            Kentucky, U of                  2              Virginia Mason CCOP                          1
            Loyola University               2              Total (26 Institutions)                     60
            Utah, U of                      2


                                  Registration, Eligibility, and Evaluability
                                           Classified by Platinum Sensitivity
                                              Data as of January 1, 2005
                                                                             Platinum-           Platinum-
                                                             TOTAL            sensitive          refractory

             NUMBER REGISTERED                                    60              30                 30
               ELIGIBLE                                           60              30                 30
                 Analyzable, Pend. Elig.                           1               1                  0
                 Not Analyzable                                    3               1                  2

                   RESPONSE ASSESSMENT
                     Determinable                                 32              15                 17
                     Not Determinable                             13               8                  5
                     Too Early                                    12               6                  6

                   ADVERSE EVENT ASSESSMENT
                     Evaluable                                    55              28                 27
                     Too Early                                     2               1                  1


                                             Patient Characteristics
                                           Classified by Platinum Sensitivity
                                              Data as of January 1, 2005
                                             Platinum-sensitive            Platinum-refractory
                                                   (n=29)                         (n=28)

                      AGE
                        Median               66.5                          61.9
                        Minimum              44.4                          22.6
                        Maximum              83.4                          85.3

                      SEX
                        Males                18           62%              15             54%
                        Females              11           38%              13             46%

                      HISPANIC
                        Yes                   1            3%               0               0%
                        No                   28           97%              28             100%

                      RACE
                        White                27           93%              26             93%
                        Black                 1            3%               2              7%
                        Asian                 1            3%               0              0%




52   LUNG                                   SOUTHWEST ONCOLOGY GROUP                                          APRIL 7 - 10, 2005

                                                          S0327/II
                                                  Treatment Summary
                                              Classified by Platinum Sensitivity
                                                 Data as of January 1, 2005
                                                                                   Platinum-    Platinum-
                                                               TOTAL                sensitive   refractory

                 NUMBER ON PROTOCOL TREATMENT                          2                1            1

                 NUMBER OFF PROTOCOL TREATMENT                        55               28           27
                   REASON OFF TREATMENT
                     Adverse Events or side effects                    7                3            4
                     Refusal unrelated to adverse events               0                0            0
                     Progression/relapse                              38               20           18
                     Death                                             3                0            3
                     Other - not protocol specified                    3                2            1

                     Reason under review                               4                3            1
                 MAJOR PROTOCOL DEVIATIONS                             1                1            0




APRIL 7 - 10, 2005                             SOUTHWEST ONCOLOGY GROUP                                      LUNG   53

                                                           S0327/II
                   Number of Patients with a Given Type and Grade of Adverse Event
                                              Classified by Platinum Sensitivity
                                 Adverse Events Unlikely or Not Related to Treatment Excluded
                                                 Data as of January 1, 2005
                                               Platinum-sensitive                        Platinum-refractory
                                                     (n=28)                                     (n=27)

                                                    Grade                                       Grade
      ADVERSE EVENT                              Unk     0   1      2    3   4   5          Unk      0   1     2   3    4   5

 ALT                                               0   24    2      1    1   0   0              0   25   2     0   0    0   0
 AST                                               0   25    1      1    1   0   0              0   22   2     2   1    0   0
 Acidosis                                          0   28    0      0    0   0   0              0   26   0     0   0    1   0
 Alkaline phosphatase                              0   25    2      1    0   0   0              0   22   2     2   0    1   0
 Alopecia                                          0   25    3      0    0   0   0              0   25   1     1   0    0   0
 Anorexia                                          0   20    3      4    1   0   0              0   20   1     5   0    1   0
 Bicarbonate, serum-low                            0   28    0      0    0   0   0              0   26   1     0   0    0   0
 Bilirubin                                         0   26    2      0    0   0   0              0   25   1     1   0    0   0
 Bruising                                          0   27    1      0    0   0   0              0   27   0     0   0    0   0
 CNS hemorrhage                                    0   27    0      0    0   1   0              0   27   0     0   0    0   0
 Cardiac General-other                             0   27    0      1    0   0   0              0   27   0     0   0    0   0
 Cardiac ischemia/infarction                       0   28    0      0    0   0   0              0   26   0     1   0    0   0
 Confusion                                         0   28    0      0    0   0   0              0   26   0     0   1    0   0
 Constipation                                      0   21    4      3    0   0   0              0   23   1     1   2    0   0
 Constitutional Symptoms-other                     0   28    0      0    0   0   0              0   26   0     0   1    0   0
 Cough                                             0   27    1      0    0   0   0              0   26   1     0   0    0   0
 Creatinine                                        0   26    2      0    0   0   0              0   24   0     2   1    0   0
 DIC                                               0   28    0      0    0   0   0              0   26   0     1   0    0   0
 Dehydration                                       0   23    0      5    0   0   0              0   25   0     1   0    1   0
 Diarrhea                                          0   22    6      0    0   0   0              0   23   2     1   1    0   0
 Dizziness                                         0   25    3      0    0   0   0              0   27   0     0   0    0   0
 Dry mouth                                         0   27    1      0    0   0   0              0   27   0     0   0    0   0
 Dry skin                                          0   27    1      0    0   0   0              0   27   0     0   0    0   0
 Dyspnea                                           0   27    0      0    1   0   0              0   23   0     1   0    2   1
 Edema-limb                                        0   26    1      1    0   0   0              0   24   1     1   1    0   0
 Fatigue                                           0   13    3      7    5   0   0              0   13   8     3   2    1   0
 Fever                                             0   27    1      0    0   0   0              0   25   1     1   0    0   0
 Flatulence                                        0   27    1      0    0   0   0              0   27   0     0   0    0   0
 Flushing                                          0   27    1      0    0   0   0              0   27   0     0   0    0   0
 GI Pain: abdomen                                  0   28    0      0    0   0   0              0   26   0     1   0    0   0
 GI Pain: stomach                                  0   27    0      1    0   0   0              0   27   0     0   0    0   0
 GI-other                                          0   27    0      1    0   0   0              0   27   0     0   0    0   0
 Hemoglobin                                        0   17    8      3    0   0   0              0   17   6     3   1    0   0
 Hepatobiliary-other                               0   28    0      0    0   0   0              0   26   0     1   0    0   0
 Hypercalcemia                                     0   28    0      0    0   0   0              0   26   0     0   1    0   0
 Hyperglycemia                                     0   26    1      1    0   0   0              0   24   1     2   0    0   0
 Hyperkalemia                                      0   28    0      0    0   0   0              0   25   1     0   0    1   0
 Hypernatremia                                     0   28    0      0    0   0   0              0   26   0     1   0    0   0
 Hypoalbuminemia                                   0   27    0      1    0   0   0              0   24   0     3   0    0   0
 Hypocalcemia                                      0   28    0      0    0   0   0              0   25   2     0   0    0   0
 Hypokalemia                                       0   28    0      0    0   0   0              0   24   1     0   1    1   0
 Hyponatremia                                      0   26    1      0    0   1   0              0   25   2     0   0    0   0
 Hypophosphatemia                                  0   27    1      0    0   0   0              0   27   0     0   0    0   0
 Hypotension                                       0   26    1      1    0   0   0              0   24   1     1   0    1   0
 Hypoxia                                           0   28    0      0    0   0   0              0   26   0     1   0    0   0
 INR                                               0   27    0      0    1   0   0              0   27   0     0   0    0   0
 Infection-other                                   0   28    0      0    0   0   0              0   26   0     0   0    0   1
 Leukocytes                                        0   24    3      0    1   0   0              0   26   0     1   0    0   0
 Liver dysfunction                                 1   27    0      0    0   0   0              0   26   0     0   0    1   0
 Lung Hemorrhage: nose                             0   27    1      0    0   0   0              0   27   0     0   0    0   0
 Lung Inf, 0-2 ANC: lung                           0   28    0      0    0   0   0              0   26   0     0   0    1   0
 Lymphopenia                                       0   25    1      2    0   0   0              0   27   0     0   0    0   0
 Metabolic/Lab-other                               0   25    3      0    0   0   0              0   26   1     0   0    0   0




54   LUNG                                       SOUTHWEST ONCOLOGY GROUP                                     APRIL 7 - 10, 2005

                                                              S0327/II
                     Number of Patients with a Given Type and Grade of Adverse Event
                                                          (continued)
                                              Classified by Platinum Sensitivity
                                 Adverse Events Unlikely or Not Related to Treatment Excluded
                                                 Data as of January 1, 2005
                                                         Platinum-sensitive                     Platinum-refractory
                                                               (n=28)                                  (n=27)

                                                              Grade                                   Grade
              ADVERSE EVENT                                   Unk      0 1 2        3 4 5             Unk     0 1 2 3 4 5

 Mood alteration: anxiety                                       0      26   2   0   0   0   0            0    27   0   0   0   0   0
 Mucositis, clin: oral cavity                                   0      27   1   0   0   0   0            0    26   1   0   0   0   0
 Muscle weakness: low. extrem.                                  0      27   0   1   0   0   0            0    27   0   0   0   0   0
 Muscle weakness: whole body                                    0      26   2   0   0   0   0            0    27   0   0   0   0   0
 Musculoskeletal-other                                          0      27   1   0   0   0   0            0    27   0   0   0   0   0
 Nausea                                                         0      20   4   4   0   0   0            0    18   5   3   1   0   0
 Neuro Pain: head/headache                                      0      25   2   1   0   0   0            0    25   1   1   0   0   0
 Neurop: hear. & bal.                                           0      28   0   0   0   0   0            0    26   0   1   0   0   0
 Neurop: mot-palate; phar, lar                                  0      28   0   0   0   0   0            0    26   0   1   0   0   0
 Neuropathy-motor                                               0      27   1   0   0   0   0            0    27   0   0   0   0   0
 Neuropathy-sensory                                             0      25   2   1   0   0   0            0    23   2   1   1   0   0
 Neutrophils                                                    0      26   1   0   1   0   0            0    26   1   0   0   0   0
 Pain-other                                                     1      26   1   0   0   0   0            0    27   0   0   0   0   0
 Pain: tumor pain                                               0      27   0   1   0   0   0            0    26   0   0   1   0   0
 Pancreatitis                                                   0      27   0   0   1   0   0            0    27   0   0   0   0   0
 Platelets                                                      0      13   6   3   5   1   0            0    17   5   2   2   1   0
 Pleural effusion                                               0      27   0   1   0   0   0            0    27   0   0   0   0   0
 Pneumonitis                                                    0      27   0   1   0   0   0            0    26   0   0   0   1   0
 Pruritus                                                       0      28   0   0   0   0   0            0    26   1   0   0   0   0
 Rash                                                           0      25   2   1   0   0   0            0    25   1   1   0   0   0
 Renal failure                                                  0      28   0   0   0   0   0            0    26   0   0   0   1   0
 Renal-other                                                    0      28   0   0   0   0   0            0    26   0   0   1   0   0
 Somnolence                                                     0      28   0   0   0   0   0            0    26   0   0   1   0   0
 Supra Arrhyth: Sinus Arrhyth                                   0      28   0   0   0   0   0            0    26   0   1   0   0   0
 Supra Arrhyth: Sinus Tachy.                                    0      26   2   0   0   0   0            0    26   1   0   0   0   0
 Sweating                                                       0      28   0   0   0   0   0            0    26   1   0   0   0   0
 Taste alteration                                               0      27   1   0   0   0   0            0    27   0   0   0   0   0
 Thrombosis/embolism                                            0      27   0   0   1   0   0            0    27   0   0   0   0   0
 Tremor                                                         0      27   1   0   0   0   0            0    27   0   0   0   0   0
 Voice changes                                                  0      27   1   0   0   0   0            0    27   0   0   0   0   0
 Vomiting                                                       0      22   5   1   0   0   0            0    24   2   1   0   0   0
 Weight Loss                                                    0      24   4   0   0   0   0            0    25   2   0   0   0   0
 Weight gain                                                    0      27   1   0   0   0   0            0    27   0   0   0   0   0

 MAXIMUM GRADE ANY ADVERSE EVENT
 Number                                                         0       2 6 7       10 3 0               0     5 3 7 7 3 2




APRIL 7 - 10, 2005                              SOUTHWEST ONCOLOGY GROUP                                               LUNG        55

                                                            S0327/II
                                                    S0339 Phase II
      A Phase II Trial of Gemcitabine, Carboplatin and PS-341 (NSC-681239) in
         the First-Line Treatment of Advanced Non-Small Cell Lung Cancer
                                      (NSCLC)

     Study Coordinators:                                              Date Activated:
        A Davies, P Lara                                                 1/15/2004
     Statisticians:                                                   Date Closed:
         J McCoy, J Crowley                                               10/1/2004
     Data Coordinator:
        L Kaye



     Objectives                                                       diotherapy, or a new lesion must be present. Pa-
     To assess overall survival in chemo-naive pa-                    tients with brain metasteses are not eligible.
     tients with advanced non-small cell lung cancer                  Prior radiation therapy and surgery are allowed.
     (NSCLC) treated with a combination of gemcit-                    Patients who have received any prior systemic
     abine, carboplatin and PS-341.                                   chemotherapy or biologic agent for non-small cell
     To assess the response rate (confirmed plus un-                  lung cancer are not eligible.
     confirmed, complete plus partial), in the subset of              All patients must have a Zubrod performance
     patients with measurable disease, progression-                   status of 0-1 with adequate hematologic and renal
     free survival, and quantitative toxicities in this               function.
     group of patients treated with this regimen.
                                                                      Accrual Goals
     To investigate in an exploratory manner, the as-                 Ninety-nine eligible patients will be accrued to
     sociation of levels of hypoxia-induced secreted                  this study.
     proteins and tumor DNA in plasma, levels of
     apoptosis-associated proteins in tumor tissue, and               Summary Statement
     the changes in the levels of PS-341 modulated                    This trial met its accrual goal and closed on Oc-
     proteins in peripheral white blood cells with pa-                tober 1, 2004 with 121 patients registered. Three
     tient response and survival.                                     patients are currently listed as ineligible. One pa-
                                                                      tient never started treatment and is not analyz-
     Patient Population                                               able.
     Patients must have newly diagnosed, histologi-
     cally or cytologically proven selected Stage IIIB                There have been three treatment-related deaths
     or Stage IV non-small cell lung cancer, or recur-                among 111 evaluated patients. One patient died
     rent disease after previous surgery and/or radia-                of pneumonitis, one died of thrombosis with su-
     tion. Both measurable and non-measurable dis-                    praventricular arrhythmia, and one died due to
     ease are allowed. There must be disease outside                  multi-organ failure. Forty-seven additional pa-
     the area of any previous surgical resection or ra-               tients have experienced Grade 4 toxicity, primar-
                                                                      ily hematologic.




56     LUNG                                    SOUTHWEST ONCOLOGY GROUP                                    APRIL 7 - 10, 2005

                                                           S0339/II
                                    Initial Registrations By 1 Month Intervals

                30




                20




                                                                                                      28
                                                                                            24
                                                                                                                     21
                10

                                                                             14
                                                  12          11
                                    7
                        4

                 0
                      FEB          MAR            APR       MAY             JUN             JUL      AUG             SEP
                      2004         2004           2004      2004            2004            2004     2004            2004
                                                           Time of Registration
                                                               CBDCA/GEM/PS-341



                                                  Registration by Institution
                                                         Total                                                              Total
      Institutions                                       Reg                 Institutions                                   Reg

      Grand Rapids CCOP                                  13                  Hawaii MBCCOP, U of                              2
      Loyola University                                  13                  John Muir Med Ctr/Davis, U of CA                 2
      Southeast CCC CCOP                                  9                  Kansas, U of                                     2
      Ozarks Reg CCOP                                     8                  Puget Sound                                      2
      St Francis/Stormont/Kansas, U of                    7                  Quad Cities/Genesis/Loyola University            2
      Central IL CCOP                                     5                  Rockwood Clinic, PS/Puget Sound                  2
      Michigan, U of                                      5                  Santa Rosa CCOP                                  2
      Montana CCOP                                        5                  St Elizabeth's MC/Davis, U of CA                 2
      St Louis CCOP                                       5                  St Louis University                              2
      Wichita CCOP                                        5                  Upstate Carolina                                 2
      Thompson Ca Surv Ctr/San Antonio, U of TX           4                  Dayton CCOP                                      1
      City of Hope Med Ctr                                3                  Desert Hospital/So Calif, U of                   1
      New Mexico MBCCOP                                   3                  Hem/Onc Associates/Utah, U of                    1
      Northwest CCOP                                      3                  Poudre Valley Hosp/Colorado, U of                1
      Sutter Hlth Western/Davis, U of CA                  3                  Salina Reg Hlth Ctr/Kansas, U of                 1
      BAMC/WHMC                                           2                  Utah, U of                                       1
      Davis, U of CA                                      2                  Total (33 Institutions)                        121




APRIL 7 - 10, 2005                                SOUTHWEST ONCOLOGY GROUP                                                    LUNG   57

                                                                 S0339/II
                                    Registration, Eligibility, and Evaluability
                                                 Data as of February 8, 2005
                                                CBDCA/                                                        CBDCA/
                                               GEM/PS-341                                                    GEM/PS-341

     NUMBER REGISTERED                              121                RESPONSE ASSESSMENT
       INELIGIBLE                                     3                  Determinable                              74
       ELIGIBLE                                     118                  Not Determinable                          19
         Analyzable, Pend. Elig.                      1                  Too Early                                 24
         Not Analyzable                               1
                                                                       ADVERSE EVENT ASSESSMENT
          BASELINE DISEASE STATUS                                        Evaluable                                111
            Measurable                              109                  Too Early                                  6
            Non Measurable                            5
            Too Early                                 3


                                                Patient Characteristics
                                                 Data as of February 8, 2005
                                   CBDCA/GEM/PS-341                                         CBDCA/GEM/PS-341
                                       (n=117)                                                  (n=117)
             AGE                                               RACE
               Median               64.1                         White                      106        91%
               Minimum              28.4                         Black                        5         4%
               Maximum              78.8                         Asian                        2         2%
                                                                 Native American              1         1%
             SEX                                                 Multi-Racial                 1         1%
               Males                69            59%            Unknown                      2         2%
               Females              48            41%

             HISPANIC
               Yes                   3             3%
               No                  114            97%


                                                 Treatment Summary
                                                 Data as of February 8, 2005
                                                                                    CBDCA/
                                                                                   GEM/PS-341

                                   NUMBER ON PROTOCOL TREATMENT                        23

                                   NUMBER OFF PROTOCOL TREATMENT                       94
                                     REASON OFF TREATMENT
                                       Treatment completed as planned                   2
                                       Adverse Events or side effects                  32
                                       Refusal unrelated to adverse events              2
                                       Progression/relapse                             31
                                       Death                                            2
                                       Other - not protocol specified                   4

                                       Reason under review                             21
                                   MAJOR PROTOCOL DEVIATIONS                            0




58   LUNG                                      SOUTHWEST ONCOLOGY GROUP                                        APRIL 7 - 10, 2005

                                                            S0339/II
                     Number of Patients with a Given Type and Grade of Adverse Event
                                 Adverse Events Unlikely or Not Related to Treatment Excluded
                                                 Data as of February 8, 2005
                                    CBDCA/GEM/PS-341                                                        CBDCA/GEM/PS-341
                                        (n=111)                                                                 (n=111)

                                               Grade                                                                  Grade
       ADVERSE EVENT              Unk      0     1     2   3 4 5               ADVERSE EVENT              Unk     0    1   2    3     4 5

 ALT                                 0    74    21    9 6 1 0            Hypopigmentation                   0   110    1    0 0 0 0
 AST                                 0    82    18    7 4 0 0            Hypotension                        0    98    4    5 3 1 0
 Acne                                0   110     1    0 0 0 0            Hypoxia                            0   110    0    0 1 0 0
 Alkaline phosphatase                0    89    19    2 1 0 0            Inf, 0-2 ANC: cath.-related        0   109    0    2 0 0 0
 Allergic reaction                   0   105     4    2 0 0 0            Infection-other                    0   110    0    1 0 0 0
 Alopecia                            0    99     9    3 0 0 0            Injection site reaction            0   110    0    1 0 0 0
 Anorexia                            0    81    21    6 3 0 0            Insomnia                           0   105    3    3 0 0 0
 Bilirubin                           0   105     3    2 1 0 0            Leukocytes                         0    27   16   28 36 4 0
 Blurred vision                      0   110     1    0 0 0 0            Liver dysfunction                  1   109    0    1 0 0 0
 Bronchospasm                        0   110     0    1 0 0 0            Lung Hemorrhage: bronchopulm.      0   110    1    0 0 0 0
 CPK                                 0   110     0    1 0 0 0            Lung Hemorrhage: nose              0   110    1    0 0 0 0
 Cardiac ischemia/infarction         0   110     0    0 1 0 0            Lung Hemorrhage: resp. tract       0   110    1    0 0 0 0
 Constipation                        0    72    26   12 1 0 0            Lung Inf, 0-2 ANC: bronch.         0   110    0    1 0 0 0
 Constitutional Symptoms-other       0   110     1    0 0 0 0            Lung Inf, 0-2 ANC: lung            0   110    0    0 1 0 0
 Cough                               0   106     4    1 0 0 0            Lung Inf, 3-4 ANC: lung            0   110    0    0 1 0 0
 Creatinine                          0   105     3    2 1 0 0            Lung Inf, Unk ANC: lung            0   109    0    0 2 0 0
 DIC                                 0   110     0    1 0 0 0            Lung Inf, Unk ANC: up. airway      0   110    0    1 0 0 0
 Dehydration                         0   103     1    3 4 0 0            Lung Pain: chest wall              0   110    0    1 0 0 0
 Dermatology-other                   0   110     1    0 0 0 0            Lung Pain: chest/thorax            0   110    1    0 0 0 0
 Diarrhea                            0    95    13    1 2 0 0            Lymphopenia                        0   109    0    1 1 0 0
 Distension                          0   109     1    1 0 0 0            Metabolic/Lab-other                0   108    3    0 0 0 0
 Dizziness                           0   109     1    0 1 0 0            Mood alteration: anxiety           0   107    2    2 0 0 0
 Dry eye                             0   110     0    1 0 0 0            Mood alteration: depression        0   108    1    2 0 0 0
 Dyspnea                             0    89    10   10 2 0 0            Mucositis, clin: oral cavity       0   110    1    0 0 0 0
 Edema-limb                          0   108     3    0 0 0 0            Mucositis, funct: oral cav.        0   109    1    1 0 0 0
 Edema-viscera                       0   110     1    0 0 0 0            Mucositis, funct: pharynx          0   110    1    0 0 0 0
 Eye Inf, 0-2 ANC: conjunct.         0   110     0    1 0 0 0            Multi-organ failure                0   110    0    0 0 0 1
 FEV1                                0   110     0    0 1 0 0            Muscle weakness: whole body        0   110    1    0 0 0 0
 Fatigue                             0    21    45   33 9 3 0            Musculo. Pain: back                0   110    0    1 0 0 0
 Febrile neutropenia                 0   110     0    0 1 0 0            Musculo. Pain: bone                0   109    1    1 0 0 0
 Fever                               0    99    12    0 0 0 0            Musculo. Pain: joint               0   102    5    4 0 0 0
 GI Hemorrhage: lower GI             0   110     0    0 1 0 0            Musculo. Pain: limb                0   110    0    1 0 0 0
 GI Hemorrhage: rectum               0   110     0    1 0 0 0            Musculo. Pain: muscle              0   102    6    3 0 0 0
 GI Inf, 0-2 ANC: gums               0   110     0    0 1 0 0            Musculo. Pain: neck                0   110    1    0 0 0 0
 GI Pain: abdomen                    0   110     0    0 1 0 0            Nasal/paranasal reactions          0   110    1    0 0 0 0
 GI-other                            0   110     1    0 0 0 0            Nausea                             0    60   37   11 3 0 0
 GU Hemorrhage: bladder              0   110     0    1 0 0 0            Neuro Pain: head/headache          0   105    6    0 0 0 0
 GU Inf, 0-2 ANC: UTI                1   110     0    0 0 0 0            Neuro Pain: neuralg/periph nrv     0   110    0    1 0 0 0
 GU Inf, 0-2 ANC: kidney             0   110     0    1 0 0 0            Neuropathy-motor                   0   105    1    2 2 1 0
 Hearing (w/o monit. prog.)          0   109     0    1 1 0 0            Neuropathy-sensory                 0    86   17    6 2 0 0
 Heartburn                           0   110     1    0 0 0 0            Neutrophils                        0    33    6   15 36 21 0
 Hemoglobin                          0    24    37   35 13 2 0           Pain-other                         0   110    0    1 0 0 0
 Hemorrhage-other                    0   110     0    0 1 0 0            Petechiae                          0   109    0    2 0 0 0
 Hepatobiliary-other                 0   104     5    2 0 0 0            Phlebitis                          0   110    0    1 0 0 0
 Hyperglycemia                       0    96     9    5 1 0 0            Platelets                          0    14   13   18 28 38 0
 Hyperkalemia                        0   106     3    1 1 0 0            Pneumonitis                        0   106    1    0 3 0 1
 Hypermagnesemia                     0   110     1    0 0 0 0            Proteinuria                        0   109    2    0 0 0 0
 Hypertension                        0   110     1    0 0 0 0            Pruritus                           0   101    5    5 0 0 0
 Hyperuricemia                       0   110     1    0 0 0 0            Pulmonary-other                    0   110    0    1 0 0 0
 Hypoalbuminemia                     0   103     8    0 0 0 0            Rash                               0    91   12    6 2 0 0
 Hypocalcemia                        0   106     5    0 0 0 0            Renal failure                      0   110    0    0 1 0 0
 Hypoglycemia                        0   110     1    0 0 0 0            Renal-other                        0   110    1    0 0 0 0
 Hypokalemia                         0    99     8    0 3 1 0            Rigors/chills                      0   105    6    0 0 0 0
 Hypomagnesemia                      0   106     5    0 0 0 0            Secondary malignancy               0   110    0    0 1 0 0
 Hyponatremia                        0    93    15    0 3 0 0            Sexual/Repro. Pain: scrotum        0   110    1    0 0 0 0




APRIL 7 - 10, 2005                                   SOUTHWEST ONCOLOGY GROUP                                                  LUNG     59

                                                                   S0339/II
                   Number of Patients with a Given Type and Grade of Adverse Event
                                                       (continued)
                               Adverse Events Unlikely or Not Related to Treatment Excluded
                                               Data as of February 8, 2005
                                CBDCA/GEM/PS-341                                                          CBDCA/GEM/PS-341
                                    (n=111)                                                                   (n=111)

                                           Grade                                                                Grade
     ADVERSE EVENT             Unk     0    1   2   3   4   5              ADVERSE EVENT            Unk     0    1     2    3    4   5

 Skin Inf, 0-2 ANC: skin         0   110    0   1   0   0   0      Thrombosis/embolism (vasc acc)     0   109    0     0    2    0   0
 Skin Pain: skin                 0   110    1   0   0   0   0      Urinary frequency                  0   110    1     0    0    0   0
 Somnolence                      0   110    0   0   1   0   0      Urticaria                          0   110    0     0    1    0   0
 Supra Arrhyth: Atrial Fib.      0   107    1   1   1   0   1      Vomiting                           0    90   10     9    2    0   0
 Supra Arrhyth: Atrial Flut.     0   110    0   0   1   0   0      Weight Loss                        0   102    5     2    2    0   0
 Supra Arrhyth: Sinus Brady.     0   110    0   1   0   0   0      Weight gain                        0   110    0     0    1    0   0
 Supra Arrhyth: Sinus Tachy.     0   110    1   0   0   0   0      cTnT                               0   110    0     0    1    0   0
 Sweating                        0   107    4   0   0   0   0
 Syncope                         0   109    0   0   2   0   0      MAXIMUM GRADE
 Taste alteration                0   106    4   1   0   0   0        ANY ADVERSE EVENT
 Thrombosis/embolism             0   109    0   0   1   0   1      Number                             0     1    2    12   46   47   3




60    LUNG                                          SOUTHWEST ONCOLOGY GROUP                                         APRIL 7 - 10, 2005

                                                                S0339/II
                                                 S0341 Phase II
      Phase II Trial of OSI-774 (NSC-718781) in Patients with Advanced Non-
               Small Cell Lung Cancer and a Performance Status of 2

   Study Coordinators:                                             Date Activated:
      P Hesketh, A Wozniak, P Gumerlock                               9/15/2004
   Statisticians:
       K Chansky, J Crowley
   Data Coordinator:
      L Kaye



   Objectives                                                      and/or irradiation. Patients must have docu-
   To assess survival in patients with advanced non-               mented measurable disease. Recurrent disease pa-
   small cell lung carcinoma with a Zubrod per-                    tients must have measurable disease outside the
   formance status of 2 treated with OSI-774.                      area of any previous surgical resection or radio-
   To evaluate the objective tumor response rates                  therapy, or a new measurable lesion must be pre-
                                                                   sent. Patients with bronchioloalveolar carcinoma
   (confirmed plus unconfirmed, complete and par-
                                                                   or Stage IIIB tumor involving the superior sulcus
   tial), in patients with advanced non-small cell
   lung carcinoma with a Zubrod performance status                 (Pancoast Tumors) are not eligible. Patients with
                                                                   brain metastases are eligible provided they are
   of 2 treated with OSI-774.
                                                                   without symptoms and are not receiving either
   To evaluate patient report of functional and                    enzyme-inducing anticonvulsants or corticoster-
   symptom status and toxicities associated with                   oid therapy to control symptoms.
   OSI-774 in this group of patients with advanced
                                                                   Patients must not have had prior radiation therapy
   non-small cell lung cancer.
                                                                   or surgery within 3 weeks prior to registration.
   To investigate in a preliminary manner possible                 Patients must not have had prior chemotherapy,
   correlations of EGFR expression levels and/or                   hormonal, or biologic therapy for non-small cell
   EGFR polymorphisms with progression-free sur-                   lung cancer.
   vival (PFS) and overall survival.
                                                                   Patients must have adequate hematologic and he-
   To investigate in a preliminary manner possible                 patic function and a Zubrod performance status of
   correlations of activated signal pathway mole-                  2.
   cules, including basal p27 expression levels with
   response and survival.                                          Accrual Goals
                                                                   The study will accrue 65 eligible patients.
   Patient Population
   Patients must have histologically or cytologically              Summary Statement
                                                                   This study opened for accrual September 15th,
   proven newly diagnosed selected Stage IIIB or
   Stage IV advanced primary non-small cell lung                   2004. As of December 31, 2004, six patients have
   cancer or recurrent disease after previous surgery              been registered.




APRIL 7 - 10, 2005                          SOUTHWEST ONCOLOGY GROUP                                             LUNG   61

                                                        S0341/II
                  Registration by Institution
              Registrations ending December 31, 2004
                                                Total
            Institutions                        Reg

            Grand Rapids CCOP                    1
            Montana CCOP                         1
            Ozarks Reg CCOP                      1
            Poudre Valley Hosp/Colorado, U of    1
            St Francis/Stormont/Kansas, U of     1
            Upstate Carolina                     1
            Total (6 Institutions)               6




62   LUNG          SOUTHWEST ONCOLOGY GROUP             APRIL 7 - 10, 2005

                                  S0341/II
                                                 S0342 Phase II
    Phase II Selection Design Trial of Concurrent Chemotherapy + Cetuximab
     vs. Chemotherapy Followed by Cetuximab in Advanced Stage Non-Small
                            Cell Lung Cancer (NSCLC)

   Study Coordinators:                                               Date Activated:
      R Herbst, K Kelly, D Gandara                                      7/1/2004
   Statisticians:
       K Chansky, J Crowley
   Data Coordinator:
      C White




                                                        Schema

                          Carboplatin/paclitaxel/C-225                C-225 maintenance
            R
            A
            N
            D
            O
            M
            I
            Z
            E
                          Carboplatin/paclitaxel             C-225            C-225 maintenance

   Objectives                                                       To evaluate EGFR polymorphisms as a potential
   To select a regimen based on overall survival via                correlate for response to cetuximab (see S9925
   a Phase II selection design of chemotherapy in                   for details).
   conjunction with cetuximab (concurrent vs. se-
                                                                    Patient Population
   quential) for Phase III testing against chemother-               Patients must have histologically or cytologically
   apy alone in Stage IIIB and Stage IV non-small                   proven, newly diagnosed or recurrent selected
   cell lung cancer.
                                                                    Stage IIIB (by pleural effusion) or Stage IV ad-
   To evaluate response rates (confirmed and uncon-                 vanced primary non-small cell lung cancer. Pa-
   firmed, complete and partial) of patients with se-               tients with brain metastases are eligible provided
   lected Stage IIIB and Stage IV NSCLC treated                     they are without symptoms and are not receiving
   with paclitaxel and carboplatin with concurrent                  either enzyme-inducing anticonvulsants or corti-
   cetuximab or paclitaxel and carboplatin followed                 costeroid therapy to control symptoms.
   by cetuximab.                                                    Patients must not have received any prior sys-
   To evaluate the toxicities of the two treatment                  temic therapy or biologic therapy for non-small
   regimens in patients with selected Stage IIB and                 cell lung cancer. Prior radiation therapy and sur-
   Stage IV NSCLC.                                                  gery are allowed. There must be progression or
   To conduct exploratory molecular correlative                     new disease outside of the RT field or area of
                                                                    surgical resection.
   studies of the EGFR-HER signaling pathways ex-
   amining activated phosphoproteins, oncogenic                     Patients must have normal hematologic, renal and
   mutations and rates of proliferation and apoptosis               cardiac function, adequate hepatic function and a
   in patient tissues (see S9925 for details).                      Zubrod performance status of 0-1.




APRIL 7 - 10, 2005                          SOUTHWEST ONCOLOGY GROUP                                          LUNG       63

                                                         S0342/II
     Accrual Goals                                                        Summary Statement
     This trial will randomize 90 eligible patients per                   This study opened to accrual on July 1, 2004. As
     arm.                                                                 of December 31, 2004, forty-two patients have
                                                                          been registered.


                                                  Registration by Institution
                                               Registrations ending December 31, 2004
                                                    Total                                                            Total
         Institutions                               Reg            Institutions                                      Reg

         Wichita CCOP                                 7            Cancer Care NW/Puget Sound                          1
         Henry Ford Hosp                              5            Colorado, U of                                      1
         City of Hope Med Ctr                         3            Hem-Onc Consultants/Loyola University               1
         Southeast CCC CCOP                           3            Loyola University                                   1
         Augusta Onc Assoc/BAMC/WHMC                  2            Mercy General Hosp/Davis, U of CA                   1
         Davis, U of CA                               2            Montana CCOP                                        1
         Dayton CCOP                                  2            St Louis CCOP                                       1
         Desert Hospital/So Calif, U of               2            Sutter Hlth Western/Davis, U of CA                  1
         Rochester, Univ of                           2            SW Cancer & Res Ctr/San Antonio, U of TX            1
         Valley Hospital/Columbia University          2            Yakima Valley Mem/Puget Sound                       1
         BAMC/WHMC                                    1            Total (22 Institutions)                            42
         Bay Medical Center/Michigan, U of            1


                                        Registration, Eligibility, and Evaluability
                              Registrations ending December 31, 2004; Data as of January 1, 2005
                                                                                                          Chemo
                                                                                  Chemo plus             followed
                                                               TOTAL              Cetuximab           by Cetuximab

                 NUMBER REGISTERED                                  42                   21                   21
                   ELIG./ PEND. ELIG.                               42                   21                   21
                     Analyzable, Pend. Elig.                        40                   21                   19

                        BASELINE DISEASE STATUS
                          Measurable                                 3                    1                    2
                          Too Early                                 39                   20                   19

                        RESPONSE ASSESSMENT
                          Too Early                                 42                   21                   21

                        ADVERSE EVENT ASSESSMENT
                          Evaluable                                  7                    4                    3
                          Too Early                                 35                   17                   18




64     LUNG                                        SOUTHWEST ONCOLOGY GROUP                                        APRIL 7 - 10, 2005

                                                               S0342/II
                                                Patient Characteristics
                           Registrations ending December 31, 2004; Data as of January 1, 2005
                                                                          Chemo followed by
                                              Chemo plus Cetuximab           Cetuximab
                                                     (n=21)                    (n=21)

                         AGE
                           Median              65.5                       66.7
                           Minimum             39.8                       36.2
                           Maximum             76.7                       82.7

                         SEX
                           Males                8           38%           11            52%
                           Females             13           62%           10            48%

                         HISPANIC
                           Yes                  0            0%            1             5%
                           No                  21          100%           20            95%

                         RACE
                           White               20           95%           15            71%
                           Black                0            0%            3            14%
                           Asian                1            5%            2            10%
                           Unknown              0            0%            1             5%


                                                 Treatment Summary
                           Registrations ending December 31, 2004; Data as of January 1, 2005
                                                                                                  Chemo
                                                                           Chemo plus            followed
                                                             TOTAL         Cetuximab          by Cetuximab

             NUMBER ON PROTOCOL TREATMENT                         39             20                 19
             NUMBER OFF PROTOCOL TREATMENT                            3           1                  2
               REASON OFF TREATMENT
                 Treatment completed as planned                       0           0                  0
                 Adverse Events or side effects                       0           0                  0
                 Refusal unrelated to adverse events                  0           0                  0
                 Progression/relapse                                  0           0                  0
                 Death                                                0           0                  0
                 Other - not protocol specified                       0           0                  0

                 Reason under review                                  3           1                  2
             MAJOR PROTOCOL DEVIATIONS                                0           0                  0




APRIL 7 - 10, 2005                            SOUTHWEST ONCOLOGY GROUP                                       LUNG   65

                                                           S0342/II
                   Number of Patients with a Given Type and Grade of Adverse Event
                           Adverse Events Unlikely or Not Related to Treatment Excluded
                         Registrations ending December 31, 2004; Data as of January 1, 2005
                                                                                               Chemo
                                                 Chemo plus Cetuximab                  followed by Cetuximab
                                                        (n=4)                                   (n=3)

                                                        Grade                                 Grade
              ADVERSE EVENT                                0     1   2   3   4   5              0     1   2    3   4   5

 ALT                                                       3     1   0   0   0   0              3     0   0    0   0   0
 AST                                                       3     1   0   0   0   0              3     0   0    0   0   0
 Alkaline phosphatase                                      3     1   0   0   0   0              2     1   0    0   0   0
 Alopecia                                                  3     1   0   0   0   0              0     1   2    0   0   0
 Anorexia                                                  4     0   0   0   0   0              2     0   1    0   0   0
 Constipation                                              3     1   0   0   0   0              3     0   0    0   0   0
 Dyspnea                                                   3     0   1   0   0   0              3     0   0    0   0   0
 Fatigue                                                   3     0   1   0   0   0              0     2   0    1   0   0
 Hemoglobin                                                3     1   0   0   0   0              0     2   0    1   0   0
 Leukocytes                                                3     1   0   0   0   0              0     1   1    1   0   0
 Musculo. Pain: joint                                      3     0   1   0   0   0              3     0   0    0   0   0
 Neuropathy-motor                                          3     0   1   0   0   0              3     0   0    0   0   0
 Neuropathy-sensory                                        3     0   1   0   0   0              2     1   0    0   0   0
 Neutrophils                                               3     0   0   0   1   0              0     0   2    0   1   0
 Platelets                                                 4     0   0   0   0   0              2     0   1    0   0   0
 Pruritus                                                  4     0   0   0   0   0              2     1   0    0   0   0
 Rash                                                      2     2   0   0   0   0              3     0   0    0   0   0
 Weight Loss                                               4     0   0   0   0   0              2     0   1    0   0   0

 MAXIMUM GRADE ANY ADVERSE EVENT
 Number                                                    1     1   1   0   1   0              0     0   2    0   1   0




66    LUNG                                SOUTHWEST ONCOLOGY GROUP                                    APRIL 7 - 10, 2005

                                                      S0342/II
                                        S0424 Epidemiologic Study
    Molecular Epidemiology Case-Series Study of Non-Small Cell Lung Cancer
                in Smoking and Non-Smoking Men and Women

   Study Coordinators:
      C Ambrosone, R Santella, K Albain
   Statisticians:
       J Crowley, K Chansky
   Data Coordinator:
      C White



   Objectives                                                    lymphocytes are higher in females than males for
   To assess the influence of active and passive                 the same level of smoking.
   smoke, hormonal and reproductive factors, and
                                                                 Patient Population
   other exposures on gender differences in lung
                                                                 Patients must have newly diagnosed, histologi-
   cancer risk.                                                  cally proven Stage I-IIIB non-small cell lung
   To assess lung tissue from male and female pa-                cancer. Patients with stage IV disease or stage
   tients with lung cancer for specific tobacco                  IIIB disease with pleural effusion are not eligible.
   smoke carcinogen adducts, alterations in p53 and
                                                                 Patients must be registered within four months of
   K-ras genes, and expression of HER2 and ER-                   diagnosis and must have tumor blocks available
   alpha and ER-beta to determine whether these                  and be willing to provide a 30-ml blood sample
   factors vary by gender, exposure, and susceptibil-
                                                                 for testing. Patients must not have documented or
   ity factors.                                                  self-reported history of signficant memory deficit.
   To determine if polymorphisms in genes in car-
                                                                 Stratification/Descriptive Factors
   cinogen and hormone metabolism pathways are                   Patients will be stratified by gender: male vs fe-
   associated with tissue alterations, or modify asso-
                                                                 male and smoking status: ever-smoker vs never-
   ciations by exposures or gender.
                                                                 smoker.
   To measure the levels of polycyclic aromatic hy-
                                                                 Accrual Goals
   drocarbon (PAH)–DNA adducts in lymphocytes
                                                                 This study will accrue 720 patients: 120 never-
   and lung tissue and examine correlations between
                                                                 smoker patients and 240 ever-smoker patients for
   the two tissue sources, and to test the hypothesis
                                                                 each gender.
   that DNA damage levels in tissue as well as in




APRIL 7 - 10, 2005                           SOUTHWEST ONCOLOGY GROUP                                        LUNG       67

                                                         S0424
                                                    S0429 Phase I
     A Pilot (Phase I) Study of Weekly Docetaxel and Cetuximab Chemoradiation
                 for Poor Risk Stage III Non-Small Cell Lung Cancer

     Study Coordinators:
        Y Chen, K Pandya, K Kelly, D Lau
     Statisticians:
         J McCoy, J Crowley
     Data Coordinator:
        J Leaman



     Objectives                                                      chogenic Stage IIIA or selected Stage IIIB non-
     To assess the feasibility and toxicity of combined              small cell lung cancer (adenocarcinoma, large
     cetuximab, weekly docetaxel and concurrent RT                   cell carcinoma, squamous cell carcinoma or un-
     in poor risk patients with Stage III non-small cell             specified). Patients with bronchioloalveolar car-
     lung cancer (NSCLC).                                            cinoma or Stage IIIB tumor involving the supe-
                                                                     rior sulcus (Pancoast Tumors), or patients with
     To evaluate overall and progression-free survival,
                                                                     malignant pleural effusion are not eligible.
     as well as response rates (confirmed and uncon-
     firmed, complete and partial) in the subset of pa-              Patients must not have received any prior chemo-
     tients with measurable disease in this group of pa-             therapy, surgery (excluding diagnostic proce-
     tients treated with this regimen.                               dures) or radiation for lung cancer.
     To assess in a preliminary fashion, the association             Patients must have Zubrod performance status of
     of EGFR mutation, immunohistochemical stains                    0-2 with poor pulmonary function or either albu-
     of EGFR-HER signaling pathways, phosphoryla-                    min < 0.85 x ILLN or weight loss > 10% due to
     tion, proliferative markers, apoptotic markers, se-             tumor. Patients with co-morbidities prohibiting
     lected oncogene markers, and markers for angio-                 standard full-dose chemotherapy with concurrent
     genesis in biopsied pre-treatment tumor tissues                 radiation are also eligible provided they have
     with response and survival outcomes.                            Zubrod performance status of 0-1.
     To explore possible associations between changes                Accrual Goals
     in plasma angiogenic factors (VEGF, IL-8,                       Initially, 25 eligible patients will be accrued for
     bFGF) and cytokine levels (IL-6, IL-1α, ICAM                    the lowest dose level. An additional 25 patients
     and TGF-ß) and the risk of pneumonitis and                      will be accrued to the higher dose level, provided
     esophagitis.                                                    that toxicity rates at the low dose level are ac-
                                                                     ceptable as protocol-specified.
     Patient Population
     Patients must have histologically or cytologically
     proven new diagnosis of a single, primary bron-




68     LUNG                                    SOUTHWEST ONCOLOGY GROUP                                  APRIL 7 - 10, 2005

                                                           S0429/I
                                                  S0435 Phase II
     A Phase II Trial of BAY 43-9006 (NSC-724772) in Patients with Platinum-
                 Treated Extensive Stage Small Cell Lung Cancer

   Study Coordinators:
      B Gitlitz, B Glisson, P Gumerlock, W Franklin
   Statisticians:
       J McCoy, J Crowley
   Data Coordinator:
      L Kaye



   Objectives                                                       lowed by progression. Patients with brain metas-
   To evaluate the efficacy of BAY 43-9006 in                       tases are eligible provided they are without symp-
   terms of response rate (confirmed and uncon-                     toms and are not receiving either enzyme-
   firmed, complete and partial) in previously                      inducing anticonvulsants or corticosteroid therapy
   treated, platinum-sensitive and platinum-                        to control symptoms.
   refractory patients with extensive stage small cell              Prior biologic therapy, radiation therapy and sur-
   lung cancer (E-SCLC).                                            gery are allowed. There must be measurable dis-
   To assess the qualitative and quantitative toxici-               ease outside the area of any previous surgical re-
   ties of BAY 43-9006 in this patient population.                  section or radiotherapy, or a new measurable le-
                                                                    sion must be present.
   To assess overall and progression-free survival in
   this group of patients treated with BAY 43-9006.                 All patients must have a Zubrod performance
                                                                    status of 0-1 with adequate hematologic, cardiac
   To collect specimens via the Lung Cancer
                                                                    and renal function.
   Specimen Repository Protocol (S9925) in order
   to perform exploratory analyses of the relation-                 Stratification/Descriptive Factors
   ship between selected markers and patient out-                   Patients will be stratified by platinum sensitivity
   comes.                                                           status: platinum-sensitive vs platinum-resistant or
                                                                    refractory.
   Patient Population
   Patients must have histologically or cytologically               Accrual Goals
   confirmed diagnosis of extensive small cell lung                 There will be two stages of accrual. In each stra-
   cancer, with measurable disease at study entry.                  tum, if at least one response is seen in the first 20
   Patients must have received a platinum-based                     eligible patients, then 20 additional patients will
   regimen, with failure to respond or response fol-                be accrued.




APRIL 7 - 10, 2005                           SOUTHWEST ONCOLOGY GROUP                                           LUNG        69

                                                         S0435/II
                                                  S0436 Phase II
       Phase II Trial of Pemetrexed and Bevacizumab Followed by Bevacizumab
         Maintenance in Patients with Advanced Non-Small Cell Lung Cancer

     Study Coordinators:
        R Zinner, H Lenz, W Franklin, P Gumerlock, S Rafii
     Statisticians:
         J McCoy, J Crowley
     Data Coordinator:
        J Leaman



     Objectives                                                     Prior radiation therapy and surgery are allowed.
     To assess overall survival in patients with ad-                Patients with central T3 or T4 tumor masses must
     vanced non-small cell lung cancer (NSCLC)                      receive palliative radiation to at least 3,500 rads
     treated with a combination of pemetrexed and                   to this tumor mass prior to registration. Patients
     bevacizumab.                                                   may have received at most one prior systemic
                                                                    chemotherapy or agent for non-small cell lung
     To assess progression-free survival, quantitative
                                                                    cancer. No prior pemetrexed or antiangiogenic
     toxicities, and the response rate (confirmed plus
     unconfirmed, complete plus partial) in this group              regimen is allowed. Patients with known hyper-
                                                                    sensitivity to boron, mannitol or PS-341 are ineli-
     of patients treated with this regimen.
                                                                    gible.
     To investigate in an exploratory manner, the as-
                                                                    All patients must have a Zubrod performance
     sociation of molecular markers with patient re-
                                                                    status of 0-1 with adequate hematologic, renal,
     sponse and survival.
                                                                    and hepatic function. Any peripheral neuopathy
     Patient Population                                             must be no greater than Grade 1.
     Patients must have newly diagnosed, histologi-
     cally or cytologically proven selected Stage IIIB              Stratification/Descriptive Factors
                                                                    Patients will be classified by presence of central
     or Stage IV non-small cell lung cancer, or recur-
     rent disease after previous surgery and/or radia-              T3 or T4 tumor mass: Yes vs. No.
     tion. Patients must have measurable disease                    Accrual Goals
     documented by CT or MRI. Patients with more                    Ninety-nine eligible patients will be accrued to
     than ½ teaspoon of hemoptysis or hematemesis                   this study.
     within 1 month of study entry or brain metasteses
     are not eligible.




70     LUNG                                  SOUTHWEST ONCOLOGY GROUP                                   APRIL 7 - 10, 2005

                                                         S0436/II
                                                  S0509 Phase II
        A Phase II Trial of Novel Oral Anti-Angiogenic Agent AZD2171 (NSC-
                     732208) in Malignant Pleural Mesothelioma

   Study Coordinator:
      L Garland
   Statisticians:
       K Chansky, J Crowley
   Data Coordinator:
      C White



   Objectives                                                       mesothelioma not amenable to extrapleural
   To assess the objective response rate (confirmed                 pneumonectomy. Patients with known CNS me-
   and unconfirmed complete and partial response                    tastases are not eligible.
   rate) in patients with unresectable malignant pleu-              Patients must not have had prior chemotherapy,
   ral mesothelioma treated with AZD2171.                           biologic therapy, or investigational anticancer
   To assess overall and progression-free survival in               agents for any reason for this tumor. Patients may
   these patients.                                                  have received prior surgery and/or radiation ther-
                                                                    apy.
   To evaluate the frequency and severity of toxici-
   ties associated with this treatment regimen in this              Patients must have a performance status of 0-2
   patient population.                                              with adequate hematologic, hepatic and renal
                                                                    function. Patients known to be HIV-positive and
   To measure molecular correlates of the VEGF-
                                                                    receiving combination anti-retroviral therapy are
   mediated signaling pathway (tumor expression of
                                                                    not eligible.
   VEGF, and its receptors VEGFR1 (FLT-1) and
   VEGFR2 (KDR), and circulating levels of VEGF                     Accrual Goals
   and sVCAM) and to explore relationships be-                      There will be two stages of accrual. If at least one
   tween these measures and clinical outcomes.                      response is seen in the first 20 eligible patients,
                                                                    then 20 additional patients will be accrued.
   Patient Population
   Patients must have histologically confirmed diag-
   nosis of epithelial, sarcomatous, or biphasic




APRIL 7 - 10, 2005                           SOUTHWEST ONCOLOGY GROUP                                           LUNG       71

                                                         S0509/II
                                                    S0510 Phase II
     A Phase II Trial of RPR 116258 in Patients with Platinum-Treated Extensive
                           Stage Small Cell Lung Cancer

     Study Coordinators:
        M Jahanzeb, M Tarek, P Gumerlock, W Franklin
     Statisticians:
         J McCoy, J Crowley
     Data Coordinator:
        L Kaye



     Objectives                                                       without symptoms and are not receiving either
     To evaluate the efficacy of RPR 116258 in terms                  enzyme-inducing anticonvulsants or corticoster-
     of response rate (confirmed and unconfirmed,                     oid therapy to control symptoms.
     complete and partial) in previously treated, plati-              Prior biologic therapy, radiation therapy and sur-
     num-sensitive and platinum-refractory patients                   gery are allowed. There must be measurable dis-
     with extensive stage small cell lung cancer (E-                  ease outside the area of any previous surgical re-
     SCLC).                                                           section or radiotherapy, or a new measurable le-
     To assess the qualitative and quantitative toxici-               sion must be present. Concurrent treatment with
     ties of RPR 116258 in this patient population.                   potent inhibitors of cytochrome P450 3A4, such
                                                                      as ketoconazole, itraconazole and erythromycin is
     To assess overall and progression-free survival in
                                                                      not allowed.
     this group of patients treated with RPR 116258.
                                                                      All patients must have a Zubrod performance
     To collect specimens via the Lung Cancer
                                                                      status of 0-1 with adequate hematologic and renal
     Specimen Repository Protocol (S9925) in order
                                                                      function.
     to perform exploratory analyses of the relation-
     ship between selected markers and patient out-                   Stratification/Descriptive Factors
     comes.                                                           Patients will be stratified by platinum sensitivity
                                                                      status: platinum-sensitive vs platinum-resistant or
     Patient Population
                                                                      refractory.
     Patients must have histologically or cytologically
     confirmed diagnosis of extensive small cell lung                 Accrual Goals
     cancer, with measurable disease at study entry.                  There will be two stages of accrual. In each stra-
     Patients must have received a previous platinum-                 tum, if at least one response is seen in the first 20
     based regimen, with failure to respond or re-                    eligible patients, then 20 additional patients will
     sponse followed by progression. Patients with                    be accrued.
     brain metastases are eligible provided they are




72     LUNG                                    SOUTHWEST ONCOLOGY GROUP                                     APRIL 7 - 10, 2005

                                                           S0510/II
                        C30102 Phase III SWOG Endorsed CTSU Study
                                         Coordinating Group: CALGB
      Phase III Comparison of Catheter Based Therapy of Pleural Effusions in
            Cancer Patients (Optimal Pleural Effusion Control, OPEC)

   Participants:                                                      Date Activated:
       CALGB, CTSU                                                       5/15/2002
   Study Coordinators:
       T Demmy (CALGB), C Jumper (SWOG)




                                                         Schema
                                R
                                A              Chest Tube + Talc Slurry
                                N
                                D
                                O
                                M
                                I
                                Z
                                A
                                T
                                I
                                O
                                               Small (PleurX) Catheter
                                N
   Objectives                                                         Patient Population
   To compare the proportion of patients with symp-                   Patients must have radiologic evidence of unilat-
   tomatic malignant pleural effusions who are suc-                   eral effusion requiring sclerosis or ongoing drain-
   cessfully treated and maintain effusion control 30                 age and a history of histologically proven malig-
   days after treatment with chest tube/talc slurry or                nancy.
   small (PleurX) catheter.                                           Patients must not have had prior intrapleural ther-
   To test whether patients undergoing either small                   apy.
   catheter drainage or chest tube and talc slurry                    Patients must be at least 18 years of age and have
   have similar quality of life (QOL) seven and 30                    adequate hematologic function with ECOG per-
   days post-treatment.
                                                                      formance status of 0-2. Patients must have no ac-
   To compare the patient acceptance and satisfac-                    tive pleural infection, allergy to talc, or other sur-
   tion with each therapy.                                            gical contraindication to talc usage.
   To compare treatment arms relative to the level of                 Stratification/Descriptive Factors
   symptoms and dyspnea experienced by patients                       Patient randomization will be stratified by (1) in-
   post-treatment.                                                    patient status: yes vs. no, (2) disease type: breast
   To compare the types, causes, and rates of early                   vs. lung vs. other and (3) concurrent chemother-
   technical failures and 30-day effusion recurrences                 apy: yes vs. no.
   of both arms and the methods used to control                       Accrual Goals
   these failures.                                                    Five hundred thirty eligible patients will be ac-
   To compare the durability of pleurodesis at 60                     crued to this study.
   days between the two techniques.
   To compare mortality, morbidity and common
   surgical complications between the two arms.

APRIL 7 - 10, 2005                           SOUTHWEST ONCOLOGY GROUP                                              LUNG        73

                                                         C30102/III
     Summary Statement                                                     (http://www.ctsu.org/) for information and regis-
     The Southwest Oncology Group has endorsed                             tration procedures.
     this study through the Cancer Trials Support Unit                     CALGB reports that as of December 31, 2004, 67
     (CTSU) of the National Cancer Institute.                              patients were registered to this study including
     Please contact the CTSU directly either by phone                      four SWOG registrations. The complete summary
     (1-888-823-5923)     or   on     their   website                      of this study from CALGB is available on the
                                                                           Southwest Oncology Group website.


                                             Registration by Institution
                                         Registrations ending December 31, 2004
                                                                                 Total
                                        Institutions                             Reg

                                        BAMC/WHMC                                  2
                                        Davis, U of CA                             1
                                        St Joseph Med Ctr/So Calif, U of           1
                                        Total (3 Institutions)                     4




74     LUNG                                   SOUTHWEST ONCOLOGY GROUP                                        APRIL 7 - 10, 2005

                                                            C30102/III
                                        E5597 Phase III Intergroup
                                          Coordinating Group: ECOG
     Phase III Chemoprevention Trial of Selenium Supplementation in Persons
                with Resected Stage I Non-Small Cell Lung Cancer

   Intergroup Participants:                       Date Activated:
       ECOG, SWOG, ACOSOG, CALGB, NCCTG, NCIC CTG    12/1/2000
   Study Coordinators:
       D Karp (ECOG), O Kucuk, R Marks (NCCTG),
       G Clamon (CALGB), O Liptay (ACOSOG),
       C McNamee (NCIC CTG)
   Statistician:
       J Crowley
   Data Coordinator:
      C White




                                                         Schema
                                                            R
                     R
                                                            A
                     E
                                                            N                 Selenium Yeast
                     G
                                                            D
                     I
                                                            O
                     S   4-Week Run in Period               M
                     T
                                                            I                 (Double Blinded)
                     R
                                                            Z
                     A
                                                            A
                     T
                                                            T
                     I
                                                            I                 Placebo Yeast
                     O
                                                            O
                     N
                                                            N
   Objectives                                                        disease. Patients between six months and 36
   To evaluate the efficacy of selenium supplemen-                   months from date of surgical resection are eligi-
   tation in reducing the incidence of second pri-                   ble. Patients with synchronous lesions (lung and
   mary lung tumors in patients who have been                        non-lung) or metastasis, even if resectable, are
   treated for Stage I non-small cell lung cancer with               not eligible. There must be no history of greater
   complete surgical resection.                                      than one lung cancer primary at any time. A chest
                                                                     x-ray ≤8 weeks prior to randomization must show
   To evaluate the qualitative and quantitative toxic-
                                                                     no sign of new or recurrent lung cancer.
   ity of a selenium supplementation in a daily ad-
   ministration schedule.                                            Patients must not have received or plan to receive
                                                                     chemotherapy or radiotherapy for lung cancer.
   To compare the incidence of specific cancers and
   mortality from cancer as well as overall survival                 Patients currently taking mineral, herbal, phyto-
   of patients treated with selenium supplementation                 chemical, or vitamin supplements that do not con-
   vs. patients treated with placebo.                                tain selenium must agree either to continue taking
                                                                     the same supplement(s), on the same schedule for
   Patient Population
                                                                     the entire duration of study participation or dis-
   Patients must have undergone complete resection
                                                                     continue supplement(s) for at least two weeks
   of a histologically proven T1N0 or T2N0 non-
                                                                     prior to study entry and agree to remain off sup-
   small cell lung cancer and be currently free of


APRIL 7 - 10, 2005                           SOUTHWEST ONCOLOGY GROUP                                          LUNG       75

                                                         E5597/III
     plement(s) for the entire duration of study par-                      as ≤100 cigarettes ever); and (2) gender: male vs.
     ticipation. Any supplement(s) containing >50 mi-                      female.
     crograms of selenium are absolutely disallowed
                                                                           Cancer Control Credits
     in this study. For further restrictions on prior and
                                                                           The NCI Division of Cancer Prevention (DCP)
     on-study selenium supplementation use refer to                        has assigned 1.0 cancer control credits per regis-
     protocol.
                                                                           tration and 0.3 follow-up credits (for each year of
     Patients must be at least 18 years of age and have                    intervention, beginning year 2).
     an ECOG performance status of 0-1. Adequate
                                                                           Accrual Goals
     renal, hepatic, and hematologic function is re-
                                                                           The accrual goal is 1,960 eligible patients.
     quired.
                                                                           Summary Statement
     Following the run-in period, in order to be ran-
                                                                           ECOG reports that as of December 31, 2004 there
     domized the patient must be free of disease and
                                                                           have been 869 registrations on this study, 122 of
     must have taken at least 75% of the prescribed
                                                                           whom have been registered by SWOG.
     study pills during the run-in period.
                                                                           The complete summary of this study from ECOG
     Stratification/Descriptive Factors                                    is available on the Southwest Oncology Group
     Patients will be stratified by (1) smoking status:
                                                                           website.
     actively smoking or stopped <1 year ago vs.
     stopped ≥ 1 year ago vs. never smoked (defined

                                                   Registration by Institution
                                               Registrations ending December 31, 2004
                                                       Total                                                          Total
       Institutions                                    Reg             Institutions                                   Reg

       Beaumont CCOP                                    19             BAMC/WHMC                                        2
       St Luke's-Roosevelt/Columbia University          11             Covenant Health Sys/San Antonio, U of TX         2
       Greenville CCOP                                  10             Quad Cities/Genesis/Loyola University            2
       Highlands Onc Group/Arkansas, U of               10             William Beau Hosp/Michigan, U of                 2
       Michigan, U of                                   10             Arkansas, U of                                   1
       Cincinnati MC, U of                               7             Atlanta Reg CCOP                                 1
       St Elizabeth's MC/Davis, U of CA                  7             Madigan Army Med Ctr/BAMC/WHMC                   1
       Loyola University                                 5             Montana CCOP                                     1
       Arlington Cancer Ctr/San Antonio, U of TX         3             New Mexico MBCCOP                                1
       Boston Univ Med Ctr                               3             Northwest CCOP                                   1
       Davis, U of CA                                    3             Oakwood Hospital/Michigan, U of                  1
       Hawaii MBCCOP, U of                               3             Ozarks Reg CCOP                                  1
       Scott & White CCOP                                3             Sutter Hlth Western/Davis, U of CA               1
       Valley Hospital/Columbia University               3             U of Tennessee MC/San Antonio, U of TX           1
       Wayne State Univ                                  3             Upstate Carolina                                 1
       Western Reg CCOP                                  3             Total (31 Institutions)                        122




76     LUNG                                        SOUTHWEST ONCOLOGY GROUP                                       APRIL 7 - 10, 2005

                                                               E5597/III
                        JBR19 Phase III SWOG Endorsed CTSU Study
                                      Coordinating Group: NCIC CTG
       A Phase III Prospective Randomized, Double-Blind, Placebo Controlled
       Trial of the Epidermal Growth Factor Receptor Antagonist, ZD1839 in
       Completely Resected Stage IB, II and IIIA Non-Small Cell Lung Cancer

   Participants:                                                    Date Activated:
       NCIC CTG, CTSU                                                  11/1/2002
   Study Coordinators:
       C O'Callaghan (NCIC CTG), E Vallieres (SWOG)




                                                        Schema
                              R
                              A                ZD1839 250 mg/day
                              N
                              D
                              O
                              M
                              I
                              Z
                              A
                              T
                              I
                              O
                                               Placebo
                              N
   Objectives                                                       Stratification/Descriptive Factors
   To compare whether adjuvant treatment with                       Patient randomization will be stratified by stage:
   ZD1839 (IRESSA) is superior to placebo in pa-                    IB vs. II vs. IIIA; histologic subtype: squamous
   tients with completely resected stage IB, II and                 vs. others; post operative radiotherapy: yes vs. no
   IIIA non-small cell lung cancer in terms of over-                and gender.
   all survival and disease-free survival.
                                                                    Accrual Goals
   To confirm the prognostic significance and to as-                One thousand one hundred sixty patients will be
   sess the predictive ability of EGFR expression,                  accrued to this study.
   phosphorylation and mutations, and the likeli-
                                                                    Summary Statement
   hood of "response" to ZD1839 (IRESSA) in
                                                                    The Southwest Oncology Group has endorsed
   terms of overall survival. (A comprehensive tu-
                                                                    this study through the Cancer Trials Support Unit
   mour bank will be established and linked to the
                                                                    (CTSU) of the National Cancer Institute. Please
   clinical database for the further study of molecu-
                                                                    contact the CTSU directly either by phone (1-
   lar markers in non-small cell lung cancer.)
                                                                    888-823-5923)       or    on     their   website
   To further evaluate toxicities related to ZD1839                 (http://www.ctsu.org/) for information and regis-
   (IRESSA)                                                         tration procedures.
   Patient Population                                               NCIC CTG reports that as of December 31, 2004,
   Patients must have histologic evidence of stage                  449 patients were registered to this study includ-
   IB, II or IIIA primary non-small cell lung cancer                ing 79 CTSU registrations from SWOG institu-
   that has been completely resected.                               tions. The complete summary of this study from
                                                                    NCIC-CTG is available on the Southwest Oncol-
                                                                    ogy Group website.


APRIL 7 - 10, 2005                          SOUTHWEST ONCOLOGY GROUP                                           LUNG       77

                                                        JBR19/III
                                                 Registration by Institution
                                            Registrations ending December 31, 2004
                                                      Total                                                              Total
     Institutions                                     Reg                 Institutions                                   Reg

     Good Samaritan Hosp/Cincinnati MC, U of           7                  Beaumont CCOP                                    1
     Atlanta Reg CCOP                                  5                  City of Hope Med Ctr                             1
     BAMC/WHMC                                         5                  Columbia River CCOP                              1
     Loyola University                                 5                  Cottage Health Sys/Los Angeles, U of CA          1
     Henry Ford Hosp                                   4                  Davis, U of CA                                   1
     Kansas City CCOP                                  4                  Dayton CCOP                                      1
     Shasta Reg Med Ctr/Davis, U of CA                 4                  LSU-Shreveport                                   1
     Keesler USAF Med Ctr/Mississippi, Univ of         3                  Orange Reg Med Ctr/Columbia University           1
     Medical Ctr Clinic/Arkansas, U of                 3                  Parma Com Gen Hosp/Cleveland Clinic OH           1
     Ozarks Reg CCOP                                   3                  Puget Sound                                      1
     Rochester, Univ of                                3                  S Georgia Med Ctr/BAMC/WHMC                      1
     Arkansas, U of                                    2                  Southeast CCC CCOP                               1
     Augusta Onc Assoc/BAMC/WHMC                       2                  St Francis/Stormont/Kansas, U of                 1
     Cleveland Clinic OH                               2                  St Joseph Med Ctr/So Calif, U of                 1
     Columbus CCOP                                     2                  Sutter Hlth Western/Davis, U of CA               1
     Finger Lakes Hem/Onc/Rochester, Univ of           2                  U of Tennessee MC/San Antonio, U of TX           1
     Nyack Hospital/Columbia University                2                  Utah, U of                                       1
     Thompson Ca Surv Ctr/San Antonio, U of TX         2                  Wichita CCOP                                     1
     Bay Area CCOP                                     1                  Total (37 Institutions)                         79




78     LUNG                                      SOUTHWEST ONCOLOGY GROUP                                           APRIL 7 - 10, 2005

                                                              JBR19/III
                           R0212 Phase II-III Intergroup (RTOG-0212)
                                          Coordinating Group: RTOG
     A Phase II/III Randomization Trial of Two Dose Schedules for Delivering
     Prophylactic Cranial Irradiation for Patients with Limited Disease Small
        Cell Lung Cancer (Companion study to the International Cranial
                       Irradiation Trial, PCI 01-EULINT1)

   Intergroup Participants:                                             Date Activated:
       RTOG, SWOG, ECOG                                                    1/15/2004
   Study Coordinators:
       A Wolfson (RTOG), L Gaspar, J Bonner (ECOG)
   Statisticians:
       J Crowley, K Chansky
   Data Coordinators:
      C White, L Kaye




                                                         Schema
                             R
                             A                 2.5 Gy once daily X 10 fractions (25 Gy)
                             N
                             D
                             O
                             M
                             I                 2.0 Gy once daily X 18 fractions (36 Gy)
                             Z
                             A
                             T
                             I
                             O
                                               1.5 Gy twice daily X 24 fractions (36 Gy)
                             N
   Objectives                                                           pleted within one week prior to registration and
   To determine the impact of an increase in the to-                    have no prior external beam irradiation to the
   tal PCI dose on the incidence of brain metastases                    head or neck.
   at a minimum of two years of patient follow-up.                      Patients must have adequate neurologic and
   To determine the impact of PCI dose on overall                       hemotologic function. Patients with radiologic
   and disease-free survial, and late treatment seque-                  evidence of brain metastases or who have mini-
   lae.                                                                 mal pleural effusions of lung metastases evident
                                                                        on CXR are not eligible. Minimum pleural effu-
   To determine the impact of PCI dose and sched-
   ule on the incidence of chronic neurotoxicity and                    sions visible on chest CT is allowed.
   on quality of life.                                                  Stratification/Descriptive Factors
                                                                        Patient randomization will be stratified by age: ≤
   Patient Population
                                                                        60 vs. >60 and interval from induction therapy to
   Patients must have histologic or unequivocal cy-
                                                                        randomization: ≤ 90 days vs. 91-180 days vs.
   tologic proof of limited disease stage I-IIIB small
   cell lung cancer.                                                    >180 days.

   Patients must have achieved a complete response
   to induction chemotherapy which must be com-

APRIL 7 - 10, 2005                           SOUTHWEST ONCOLOGY GROUP                                             LUNG       79

                                                         R0212/II-III
     Accrual Goals                                                     whom have been registered by SWOG. The com-
     Two hundred sixty-four patients will be accrued                   plete summary of this study from RTOG is avail-
     to this study.                                                    able on the Southwest Oncology Group website.
     Summary Statement
     RTOG reports that as of December 31, 2004, 78
     patients were registered to this study, three of

                                             Registration by Institution
                                        Registrations ending December 31, 2004
                                                                                Total
                                    Institutions                                Reg

                                    Grand Rapids CCOP                            1
                                    Madigan Army Med Ctr/BAMC/WHMC               1
                                    Olympic Hem/Onc/Puget Sound                  1
                                    Total (3 Institutions)                       3




80     LUNG                                   SOUTHWEST ONCOLOGY GROUP                                   APRIL 7 - 10, 2005

                                                        R0212/II-III
                         R0214 Phase III SWOG Endorsed CTSU Study
                                          Coordinating Group: RTOG
         A Phase III Comparison of Prophylactic Cranial Irradiation Versus
        Observation In Patients With Locally Advanced Non-Small Cell Lung
                                      Cancer

   Participants:                                                     Date Activated:
      RTOG, CTSU                                                        11/1/2002
   Study Coordinators:
       E Gore (RTOG), L Gaspar (SWOG)




                                                         Schema
                                R
                                A             2 Gy once daily X 15 fractions (30 Gy)
                                N
                                D
                                O
                                M
                                I
                                Z
                                A
                                T
                                I
                                O
                                              Observation
                                N
   Objectives                                                        Patients must be ≥ 18 years of age and have no
   To determine whether prophylactic cranial irra-                   grade 3 or higher toxicities from previous ther-
   diation (PCI) improves survival after effective lo-               apy.
   coregional/systemic therapy for patients with lo-
                                                                     Stratification/Descriptive Factors
   cally advanced non-small cell lung cancer (LA-
                                                                     Patient randomization will be stratified by stage:
   NSCLC).                                                           IIIA vs. IIIB, histology: non-squamous cell vs.
   To determine the impact of PCI on neuropsy-                       squamous cell and previous surgery: no vs. yes.
   chology, quality of life and the incidence of CNS
                                                                     Accrual Goals
   metastases.
                                                                     One thousand fifty-eight patients will be accrued
   Patient Population                                                to this study.
   Patients must have Stage IIIA or IIIB non-small
                                                                     Summary Statement
   cell lung cancer. Patients must have no evidence
                                                                     The Southwest Oncology Group has endorsed
   of progressive disease of extracranial distant me-                this study through the Cancer Trials Support Unit
   tastases. Patients with synchronous or prior ma-
                                                                     (CTSU) of the National Cancer Institute.
   lignancy, with the exception of non-
   melanomatous skin cancer, within the past 3                       Please contact the CTSU directly either by phone
   years are not eligible.                                           (1-888-823-5923)     or     on   their   website
                                                                     (http://www.ctsu.org/) for information and regis-
   Patients must have completed all planned defini-
                                                                     tration procedures.
   tive locoregional therapy (with or without sys-
   temic therapy) and have achieved at least stable                  RTOG reports that as of December 31, 2004, 105
   disease. Patients must have no prior cranial irra-                patients were registered to this study, four of
   diation.                                                          whom have been registered by SWOG. The com-



APRIL 7 - 10, 2005                           SOUTHWEST ONCOLOGY GROUP                                          LUNG       81

                                                         R0214/III
     plete summary of this study from RTOG is avail-                   able on the Southwest Oncology Group website.


                                             Registration by Institution
                                         Registrations ending December 31, 2004
                                                                                 Total
                                  Institutions                                   Reg

                                  Asante-Rogue Med Ctr/Oregon Hlth Sci Univ        2
                                  Puget Sound                                      2
                                  Total (2 Institutions)                           4




82     LUNG                                      SOUTHWEST ONCOLOGY GROUP                               APRIL 7 - 10, 2005

                                                          R0214/III

				
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