Cancer Trials Centre News
As we journey through the Joint Biomedical Research Unit to speed
summer season we put up contract processing and to develop
behind us almost two years robust mechanisms for expanding trials
of great change since internationally. We now work within the
moving to our new unit in larger UKCRC Clinical Trials Group whilst
Tottenham Court Road, maintaining our role in the NCRI CTU
Bloomsbury. We have seen network and close links with several NCRI
a major expansion in staff, survived an Clinical Studies Groups. Our contacts with
MHRA inspection and successfully clinicians, clinical groups and industry are
integrated into the newly opened UCL of vital importance to us, to set up and
Cancer Institute. Supplementary funding conduct trials as speedily as possible. The
from Cancer Research UK and changes in rapid expansion in scientific knowledge
our structure have strengthened the unit. and new therapeutic agents coupled with
We now have many more statisticians, the ever increasing cost and complexity of
new senior trial co-ordinators, an trials is an exciting challenge for us all,
educational programme and a new and and one we look forward to tackling with
expanding regulatory team. Our portfolio you.
continues to grow and we have an Prof Jonathan A Ledermann, Director
increasing proportion of early clinical trials Cancer Research UK and UCL Cancer
and phase II studies. The CTC is working Trials Centre
ever more closely with the UCL/UCLH
LATEST NEWS We hope that you
find this issue of
BODMA -
Following BODMA’s Cancer Trials
closure, the CTC has Centre News
taken on hosting the interesting and
training. The British
informative. Your
Oncology Data
Managers Association feedback is
(BODMA) was wound appreciated:
down at the end of newsletter@ctc.
March. We are glad to
ucl.ac.uk
report that the CTC
will take over
BODMA’s training
courses. These will be
Cancer Trials Centre (CTC) Team
based on the Basic
Data Managers
Training Course and The increase in patients in open trials at the CTC
Advanced Course in
Cancer Clinical Trials.
We are running our
Total number of patients in open trials
first course in 5000
Head & neck
November.
Any enquiries please
contact bodma@ctc. Gynaecological
4000
ucl.ac.uk.
Bone Mets
3000
NEW APPROACHES -
The new technology
Lung
revolutionising 2000
cancer treatments,
see p4. GI
1000
SARCOMA - a new
Lymphoma
portfolio! More info to 0
come in the next CTC Oct- Nov- Dec- Jan- Feb- Mar- Apr- May- Jun-
newsletter.
07 07 07 08 08 08 08 08 08
OUR CURRENT CONTACT DETAILS:
Cancer Research UK & UCL Cancer Trials Centre Page 1
University College London | 90 Tottenham Court Road | London W1T 4TJ
Enquiries: 020 7679 9898 | Fax: 020 7679 9899 | Randomisation line: 020 7679 9880
www.ucl.ac.uk/cancertrials
Summer issue 2008 UCL | Cancer Trials Centre
GASTROINTESTINAL
[GITeam@ctc.ucl.ac.uk]
OPEN TRIALS: ACT II, XERXES, TACE, results will be presented at ASCO in 2009. It
ABC-02, PHOTOSTENT-02, EXCITE has been a very successful trial; the largest
The GI group continues to grow with trials in of its kind and it has established a network
liver, biliary tract, rectal and anal cancers of clinicians interested in this disease.
using a variety of therapies including Photostent-02 (see also p4) is in the
chemotherapy, radiation, surgery, feasibility stage and additional centres have
photodynamic therapy and transarterial recently joined. TACE will reach its target
chemoembolisation. ARISTOTLE, a trial of accrual of 80 patients by the end of the year.
radiotherapy and chemotherapy in rectal Recruitment into EXCITE, a phase II study
cancer is in development. Also in with irinotecan, capecitabine and cetuximab
development is a surgical trial for metastatic in conjunction with preoperative
colorectal cancer and a brachytherapy study radiotherapy for locally advanced rectal
for locally advanced rectal cancer in frail cancer, will open this summer. XERXES has
patients. ACT II - the largest trial in anal been on hold for the last year while the
cancer ever conducted—which opened in second stage is planned taking account of
2001, will close towards the end of this year. recent published data. CHRONICLE closed
The biliary tract cancer trial, ABC-02, has this year and data are being prepared for
recently reached target accrual and the publication.
LUNG
[Allan Hackshaw: a.hackshaw@ctc.ucl.ac.uk]
OPEN TRIALS: LungSEARCH, LungSTAR, & Co. The trial will compare platinum and
SOCCAR, TACTIC, TOPICAL non-platinum chemotherapy following ERCC1
The number of CTC staff working on lung stratification in advanced NSCLC patients.
trials has increased significantly over the We have been funded for a new radiotherapy
past few years. This has enabled us to trial from the Feasibility Study Committee,
expand our trial portfolio and encompass a IDEAL-CRT, which will look at radiotherapy
greater breadth of expertise. We have five dose escalation in bulky stage II/III NSCLC.
open trials – along with an exciting new The thalidomide studies, Studies 12 and 14,
study, ET-ERCC1, which has just received are being prepared for publication.
approval from CTAAC and funding from Lilly
GYNAECOLOGICAL CLOSED BREAST
[Lindsay James: [Sharon Forsyth:
l.james@ctc.ucl.ac.uk] s.forsyth@ctc.ucl.ac.uk]
OPEN TRIALS: BIBF the role of
1199.9, CxII, BRCA chemotherapy in Thanks to the hospitals who returned
This year we completed patients receiving Case Report Forms for the Over 50s
our first NCRI academic/ radiation for endometrial (2 v 5 years Tamoxifen), Under 50s
industry partnerships cancer. A new ovarian (Tamoxifen v Zoladex v Tamoxifen/
trial. As you will see trial, mEOC, in the rare Zoladex v control) and DCIS trials.
from the ‘New mucinous subtype of Your efforts tracking down old patient
Approaches’ section on ovarian cancer will notes were appreciated. We will
p4, BIBF 1199.9, a trial compare oxaliplatin + continue to accept data received for
with a novel VEGFR TKI, capecitabine with the >/<50s trials for the EBCTCG
BIBF 1120, did not carboplatin + paclitaxel. World Breast Overview. The 2007
follow our standard O2—a trial of carboplatin meta-analysis for the <50s trial has
approach to coordinating and gemcitabine in now been done and the manuscript
a trial. Despite a number ‘platinum resistant’ will be submitted for publication as
of early challenges the ovarian cancer was part of the ZIPP collaboration.
recruitment was presented at ECCO 14 We will soon be preparing the CRC1
completed in March and is being prepared for (Kings Cambridge) trial database for
2008. CxII is expected publication. BRCA is an analysis on mature data. This
to close later this open in 16 centres in the evaluated the role of prophylactic
summer. We are UK and is about to open radiotherapy following simple
opening PORTEC-3, a in international sites— mastectomy for early breast cancer, in
new international Germany, Israel, Spain, terms of local recurrence-free and
endometrial cancer trial. Portugal and Sweden. overall survival. We will shortly chase
This study will evaluate for long-term follow-up data.
Page 2
Summer issue 2008 UCL | Cancer Trials Centre
LYMPHOMA
[Paul Smith: p.smith@ctc.ucl.ac.uk]
OPEN TRIALS: CHOP-Campath, CORAL, prognostic indicator after two cycles of
FoRT, GEMBEX, ITCL, Mantle Cell, PET, treatment. Clearly defining the role of PET
RCHOP 14 vs 21, RCODOX M/IVAC, RGCVP, scanning in Hodgkin lymphoma is also of
Watch and Wait, The 18-30 Study vital interest. The current trial in early stage
The number of people working in the Hodgkin lymphoma will provide important
lymphoma team has more than doubled in information about the feasibility of
the last two years and now consists of a de-escalating treatment based on the results
team of 13. The RCHOP 14 vs 21 trial is of a PET scan. This strategy of adapting
likely to close in autumn 2008 and will be treatment based on the results of PET scans
critical in providing the answer as to will be further developed in a new trial for
whether 14 day R-CHOP is better than 21 patients with newly diagnosed, advanced
day R-CHOP. There is an important Hodgkin lymphoma.
sub-study associated with this trial which is
investigating the role of PET scanning as a
BONE METASTASES
[Heather Purnell: h.purnell@ctc.ucl.ac.uk]
OPEN TRIALS: RIB, SCORAD, SC20 hosted SC20 Trial. A new trial has been
The RIB Trial underwent an amendment in added to the Bone Metastasis trial portfolio –
2007 to limit recruitment to primary the SCORAD Feasibility Study. This study
prostate patients presenting with painful investigates changes in neurological
bone metastases (previously this included functioning following single or multi-fraction
primary cancers breast and lung). Accrual radiotherapy treatment regimes for patients
remains steady and the trial is set to close with spinal cord compression.
to recruitment in late 2009, as will our other
bone metastases trial - the internationally
HEAD AND NECK A DAY IN THE LIFE
[Kathryn Monson: OF A DATA
k.monson@ctc.ucl.ac.uk] MANAGER:Vikki Steel
OPEN TRIALS: examine whether a “The role of a Data Manager…
EaStER, HiLo combination of RAD001 …is very much given away in the
We manage four head (Everolimus) and job title. In a nutshell, I manage
and neck cancer trials: Docetaxel can be given data, although there are many
HiLo - is the first safely to patients with different facets to this. My main
national trial of thyroid advanced or recurrent priority is to ensure the
cancer in the UK. It head and neck cancer. Information entered onto the Case
examines whether We will register up to Report Forms is transposed to the
1.1 GBq activity eighteen patients into database and that any anomalous
radioiodine ablation is the dose escalation data is picked up and queried.
as effective as 3.7 GBq phase I study, and The latter part often means I am
and if Thyrogen® randomise 100 more the bane in the life of many a
(rhTSH) impacts on into the multicentre research nurse, as queries can
ablation success. phase II trial. range from the vital to the
Eighteen centres are UKHAN - Thank you for pedantic. Key to the data
participating and all follow-up received management role is ensuring data
fourteen are in set up. last year. The last is both accurate and complete, as
EaStER - this feasibility remaining follow-up is making sure a sufficient
study, comparing data should be numbers of eligible patients are
endoscopic excision available soon. The recruited into the trial. Without the
and radiotherapy analysis will be patients, there would be no data
treatment for early completed during the to work with and data are central
stage glottic cancer, summer, and the to the outcome of a trial, as it is
will open shortly in its manuscript will be largely the results of the final
sixth centre. submitted later in the analysis of the data that will deem
DORA (in set up) - This year. whether or not a trial has been
phase I/randomised successful.”
phase II study will
Page 3
NEW APPROACHES
BIBF 1199.9 PHOTODYNAMIC THERAPY (PDT)
[l.james@ctc.ucl.ac.uk] [s.hughes@ctc.ucl.ac.uk]
BIBF 1199.9 has program accessed PDT is a relatively for use in skin
proved to be an using a laptop/secure new treatment cancers and
important first – a internet connection— which can be used cancers of the head
collaboration a challenge for some to destroy cancer and neck.
between the NCRI NHS IT departments! cells in patients Photostent-02,
and industry. The BIBF 1199.9 has with specific types which is being run
trial was designed given us all of tumours. A at the CTC, is
through the NCRI experience with photosensitive drug investigating
group and is several new trial is given to the possible benefits in
managed by the CTC procedures; it has patient, which is patients with biliary
and sponsored by been an important inactive in the tract cancer. This
Boehringer learning curve. absence of light. trial, which is the
Ingelheim. It Importantly it will, Later a surgeon or largest
involved many new we hope, be one of a physician will direct international PDT
approaches to trial series of ‘Early a laser at the area clinical trial for
conduct, not least Phase’ trials of the cancer biliary tract cancers
the 24hr Interactive developed by the causing activation known to date,
Voice Recognition Ovarian sub-group of of the drug and aims to establish
System for the NCRI induction of a PDT as a standard
randomisation, drug Gynaecological reaction, which treatment for BTC
allocation and Clinical Studies causes the cancer cancer patients in
unblinding. Data Group and run in an cells to be the UK.
were entered using a academic setting. destroyed. PDT is
Remote Data Capture currently licensed
SELECTED CTC PUBLICATIONS 2007-2008
1. Bloor AJ, Thomson K, Chowdhry N, Verfuerth S, Ings SJ, Chakraverty R, Linch DC, Goldstone AH, Peggs KS, Mackinnon
S. High response rate to donor lymphocyte infusion after allogeneic stem cell transplantation for indolent non-Hodgkin
lymphoma. Biol Blood Marrow Transplant. 2008;14:50-8
2. Hackshaw AK, Farrant H, Bulley S, Seckl M, Ledermann J. Setting up non-commercial clinical trials takes too long in the
UK: findings from a prospective study. J Royal Soc Med (in press)
3. Kulkarni AA, Loddo M, Leo E, Rashid M, Eward KL, Fanshawe TR, Butcher J, Frost A, Ledermann JA, Williams GH, Stoeber
K. DNA replication licensing factors and aurora kinases are linked to aneuploidy and clinical outcome in epithelial ovarian
carcinoma. Clin Cancer Res 2007;13:6153-61
4. Ledermann JA. Lessons learned from a decade of clinical trials of high-dose chemotherapy in ovarian cancer. Int J
Gynecol Cancer 2008;18 Suppl 1:53-8
5. Lee S-M, Buchler T, James L, Snee M, Ellis P, Hackshaw A. Phase II trial of carboplatin and etoposide with thalidomide in
patients with poor prognosis small-cell lung cancer. Lung Cancer 2008; 59:364-8
6. Mallick U, Harmer C, Hackshaw A. The HiLo Trial: a Multicentre Randomised Trial of High- versus Low-dose Radioiodine,
with or without Recombinant Human Thyroid Stimulating Hormone, for Remnant Ablation after Surgery for
Differentiated Thyroid cancer. Clin Oncol 2008; 20: 325-6
7. Mobus V, Wandt H, Frickhofen N, Bengala C, Champion K, Kimmig R, Ostermann H, Hinke A, Ledermann JA. Phase III
trial of high-dose sequential chemotherapy with peripheral blood stem cell support compared with standard dose
chemotherapy for first-line treatment of advanced ovarian cancer: intergroup trial of the AGO-Ovar/AIO and EBMT. J Clin
Oncol 2007;25(27):4187-93
8. Paulussen M,Craft AW,Lewis I,Hackshaw A,Weston C,Douglas C,Ahrens S,Dunst J,Schuck A,Winkelmann W,Exner GH,
Köhler G,Leuschner I,Poremba C,Zoubek A, Ladenstein R,van den Berg H, Hunold A,Cassoni A,Spooner D,Grimer R,
Whelan J,McTiernan A,,Jürgens H. The European Intergroup Cooperative Ewing's Sarcoma Study Group. EICESS-92 –
Results of two randomised trials of the European intergroup Cooperative Ewing's Sarcoma Study. J Clin Oncol (in press)
9. Peggs KS, Sureda A, Qian W, Caballero D, Hunter A, Urbano-Ispizua A, Cavet J, Ribera JM, Parker A, Canales M,
Mahendra P, Garcia-Conde J, Milligan D, Sanz G, Thomson K, Arranz R, Goldstone AH, Alvarez I, Linch DC, Sierra J,
Mackinnon S; UK and Spanish Collaborative Groups. Reduced-intensity conditioning for allogeneic haematopoietic stem
cell transplantation in relapsed and refractory Hodgkin lymphoma: impact of alemtuzumab and donor lymphocyte
infusions on long-term outcomes. Br J Haematol. 2007 139:70-80
10. Seymour MT, Maughan TS, Ledermann JA, Topham C, James R, Gwyther SJ, Smith DB, Shepherd S, Maraveyas A, Ferry
DR, Meade AM, Thompson L, Griffiths GO, Parmar MK, Stephens RJ. Different strategies of sequential and combination
chemotherapy for patients with poor prognosis advanced colorectal cancer (MRC FOCUS): a randomised controlled trial.
Lancet 2007;370:143-52
11. Spiro S,Hackshaw AK.Integration of chemo-and radiotherapy in small cell lung cancer. Minerva Pneumologica (in press)
12. Swart AM, Burdett S, Ledermann J, Mook P, Parmar MK. Why i.p. therapy cannot yet be considered as a standard
of care for the first-line treatment of ovarian cancer: a systematic review. Ann Oncol 2008;19(4):688-95
13. Trimble EL, Davis J, Disaia P, Fujiwara K, Gaffney D, Kristensen G, Ledermann J, Pfisterer J, Quinn M, Reed N,
Schoenfeldt M, Thigpen JT. Clinical trials in gynecological cancer. Int J Gynecol Cancer 2007;17:547-56
14. Wright J, Johnson P, Smith P, Horsman JM, Hancock BW. T-cell non-Hodgkin's lymphoma: treatment outcomes and
survival in 3 large UK centres. Acta Haematol. 2007;118:123-5
15. Wynne P, Newton C, Ledermann JA, Olaitan A, Mould TA, Hartley JA. Enhanced repair of DNA interstrand crosslinking in
varian cancer cells from patients following treatment with platinum-based chemotherapy. Br J Cancer 2007;97: 7-33
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