Docstoc

of SCHEMA TITLE Phase II Trial of

Document Sample
of SCHEMA TITLE Phase II Trial of Powered By Docstoc
					                                                                                 SCHEMA
TITLE:            S0722, A Phase II Trial of mTOR Inhibitor, Everolimus, (RAD001) in Malignant Pleural Mesothelioma (MPM)
PHASE II
LUNG
ELIGIBILITIES: Any potential eligibility issues should be addressed to the Data Operations Center in Seattle at 206/652-2267 prior to registration. In calculating
days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday four weeks
later would be considered Day 28. This allows for efficient patient scheduling without exceeding the guidelines. If Day 28 or 42 falls on a weekend or holiday, the
limit may be extended to the next working day.
1.       Patients must have histologically confirmed diagnosis of unresectable malignant pleural mesothelioma. Histologic subtype must be noted on the S0722
         Pre-study Form, #24275.
2.       Patients must have measurable or non-measurable disease (see Sec 10.1) documented by CT scan. Measurable disease must be assessed within 28
         days prior to registration. Non-measurable disease must be assessed within 42 days prior to registration. The CT from a combined PET/CT must not be
         used to document measurable disease unless it is of diagnostic quality as defined in Sec 10.1. All disease must be assessed and documented on the
         RECIST and Modified RECIST Baseline Tumor Assessment Form (#13281) including pleural thickness measurements for modified RECIST (see Sec
         10.5).
3.       Patients must have had prior systemically administered platinum-based chemotherapy. Pleural space washing with cisplatin does not constitute systemic
         administration. No more than two prior systemic therapeutic regimens are allowed (including biologics, targeted and immunotherapies), and at least one
         regimen must have been platinum-based. Neoadjuvant and/or adjuvant systemic therapy will not be counted as a prior regimen, assuming at least 12
         weeks have elapsed between the end of neoadjuvant/adjuvant therapy and development of progressive disease. Patients must have completed systemic
         therapy (including any chemotherapy, biologics, targeted and immunotherapies) ≥ 28 days (42 days for nitrosoureas or mitomycin C) prior to registration
         and have recovered from adverse events due to agents administered
4.       Patients may have received prior surgery (e.g., pleurectomy, pleurodesis) provided that at least 28 days have elapsed since surgery (thoracic or other
         major surgeries) and patients have recovered from all associated toxicities at the time of registration. There must be no anticipated need for major surgical
         procedures during protocol treatment.
5.       Patients must not have known CNS metastases.
6.       Institutions must offer patients participation in correlative studies as outlined in Sec 15.0.
7.       Patients may have received prior RT provided that at least 14 days have elapsed since the last treatment and patients have recovered from all associated
         toxicities at the time of registration.
8.       Patients must not have received chronic, systemic treatment with corticosteroids or another immunosuppressive agent, except corticosteroids with a daily
         dosage equivalent to prednisone ≤ 20 mg. Patients receiving corticosteroids must have been on a stable dosage regimen for a minimum of 4 weeks prior
S0722
Page 1 of 3
        to the first planned treatment with everolimus. Topical or inhaled corticosteroids are allowed.
9.      Patients must not have had prior mTOR inhibitor therapy (rapamycin, everolimus, temsirolimus [CCI-779], AP23573).
10.     Patients must not be planning to receive immunization with attenuated live vaccines.
11.     Patients must have a Zubrod Performance Status of 0 - 1 (see Sec 10.4).
12.     All patients must be 18 years of age or older.
13.     Patients must have adequate hematologic function as documented by an ANC ≥ 1,500 and a platelet ct ≥ 100,000 obtained within 28 days prior to
        registration.
14.     Patients must have adequate hepatic function as evidenced by serum bilirubin ≤ IULN. SGOT (AST) or SGPT (ALT) must be ≤ 1.5 x IULN. These tests
        must be obtained within 28 days prior to registration.
15.     Patients must have a serum creatinine ≤ 1.5 x IULN or a calculated or measured creatinine clearance ≥ 50 using the following formula. These tests
        (including creatinine if using calculated creatinine clearance) must be obtained within 28 days prior to registration.
                Calculated Creatinine Clearance = (140-age) x wt (kg) x 0.85 (if female)
                                                          72 x creatinine (mg/dl)
16.     Patients must have no evidence of bleeding diathesis or coagulopathy. Patients must have no pathologic condition other than mesothelioma that carries a
        high risk of bleeding.
17.     Patients must not be known to be HIV-positive and on antiretroviral therapy because of the potential for pharmacokinetic interactions with everolimus.
18.     Patients must not have gastrointestinal tract disease resulting in an inability to take oral or enteral medication via a feeding tube or a requirement for IV
        alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease.
19.     Patients must not be pregnant or nursing because of increased risk of harm to a nursing infant or fetus including fetal death from the chemotherapeutic
        agents. Women/men of reproductive potential must have agreed to use an effective contraceptive method.
20.     No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer,
        adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been
        disease-free for 5 years.


TREATMENT: A cycle is 28 calendar days, regardless of treatment delays.
              AGENT              DOSE        ROUTE               DAYS                       INTERVAL NOTES
        Everolimus*        10 mg/day       Oral           1 – 28             Daily There will be no pause between cycles.
         *Everolimus tablets are supplied as 5 mg tablets. Tablets should be taken in the morning with water 1 hour before or 2 hours after food (on an
empty stomach). Patients will be given a 30-day supply of the drug. Patients receiving full dose therapy will be supplied with 5 mg tablets and
instructed to take two tablets once a day.

S0722
Page 2 of 3
PRESTUDIES:
Required: H&P, Weight and PS; Disease Assessment; CBC/Differential/Platelets; Bilirubin; SGOT or SGPT; Serum Creatinine; Calculated or Measured Creatinine
Clearance; CT; Chest CT scan; Pregnancy test for childbearing women; Alk Phos; Glucose; Electrolytes; Cholesterol with Triglyceride


SPECIMEN SUBMISSION: Archived Tumor Specimen; Buffy Coat and Plasma Specimens (see Section15.0)


ACCRUAL GOAL: 20-55 participants


DRUGS SUPPLIED: Everolimus




02/09: le
12/10 : cc




S0722
Page 3 of 3

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:3
posted:9/17/2012
language:Unknown
pages:3