ALTG Clinical Trials Newsletter

Transcription

1 ALTG Clinical Trials Newsletter May 2010 President s Message Special points of interest: Travel support available for TSANZ ASM Membership fees abolished, encourage your colleagues to join Inside this issue: General Business 2 MATES Trial 2 ANTS Trial 3 NITRO Trial 3 BR29 Trial 3 PACT in NSCLC Study 4 PA in Lung Study 4 Unmet needs in Lung Cancer BR26 Trial 5 B2P2M2 5 MESORADS Trial 6 CHISEL Trial 6 4 Welcome to the 4 th ALTG newsletter! As you will see from the individual trial reports, accrual to ALTG trials remains good with >150 patients entered on trials to date. Our trial portfolio is growing and diversifying with trials involving not just systemic treatments but also trials evaluating novel delivery of radiation therapy, patient preferences, and supportive care measures. It is important for ALTG that we support and develop clinical trials covering these areas as well as novel systemic therapies. ALTG has also continually increased its membership with currently 215 active members. Our membership is also diverse, and includes medical specialists, cancer nurse coordinators, clinical research staff, research scientists, and allied health professionals. I am particularly pleased to welcome to ALTG our new consumers. ALTG now has 5 consumers forming a consumer panel. Two of our new consumers, Coral Fuata and Ian Stubbin were able to come to the ALTG meeting at TSANZ in Brisbane in March. I am sure they found the meeting full of incomprehensible medical jargon but their presence really helped us to focus on clearly explaining what we are doing and why. Maintaining and developing strong consumer input is vital to the future of ALTG. I am also pleased to welcome Dr Baerin Houghton who has joined ALTG as a research fellow. Baerin is working partly for ALTG and partly for ANZUP, the National Urologic Oncology/Prostate Prof Michael Millward ALTG President cancer trials group. I am sure his time with us will be productive. Since our last newsletter we have had the Investigator s meeting for the B2P2M2 mesothelioma trial which is almost ready for activation. Interest in this trial is high, and ALTG and the trial received some media attention after the Investigator s meeting. Thanks to the careful comments of Martin Stockler and Anna Nowak, the media reporting was pretty even without the miracle cure that often comes across when the media report on potential new cancer treatments. The next ALTG meeting will be at the Australian Lung Cancer Conference in Melbourne in October. Further details of this conference can be found at This will be an important conference for lung cancer in Australia and has an impressive list of speakers. I urge ALTG members to attend. Peter Flynn has stepped down as ALTG treasurer, and I would like to say a big thank you for his help. A call will be sent to ALTG members for interest in this position, and I am delighted that Michael Boyer has agreed to act as interim treasurer for the short-term. I would also like to thank all those who helped put together the submission for the renewal of ALTG funding to Cancer Australia. We hope to hear about this in May, so fingers crossed! ALCC 7 Upcoming Meetings 2010 The ALTG greatly acknowledges the support from: 7 9 October 2010 Australian Lung Cancer Conference Sofitel on Collins Melbourne 7 October 2010 SAC Meeting ALCC - Melbourne 7 October 2010 Combined MAC & SAC Meeting ALCC - Melbourne 8 October 2010 ALTG Meeting ALCC - Melbourne 7.30am am 8.15am am 4.00pm pm November 2010 COSA

2 Page 2 ALTG General Business Travel Support Australian Lung Cancer Conference The next ALTG meeting will be held at ALCC at Sofitel on Collins in Melbourne on the 8th October from 4.00pm to 6.30pm. Travel Support is available to all ALTG members to attend this meeting, expenses covered are airfares, taxi fares, parking and any other expenses incurred travelling to the meeting. If you are interested in receiving Travel Support, expressions of interest should be ed to Karen@lungfoundation.com.au Expansion of SAC Membership The SAC would like to welcome four new consumer members. They are Coral Fuata, Ian Stubbin, Christine Tuddenham and David Wenzel. Consumer Panel The group have now established a Consumer Panel with five consumers who will review the group s new trial concepts as well as the protocols. Two ALTG members Ms Beth Ivimey and Dr Linda Mileshkin agreed to take on the role of Consumer Liaison Officers to provide advice and assistance for Consumer Panel Members ALTG Website It is important that all ALTG members logon regularly to check upcoming meetings and other pertinent news from the meetings. If you are unable to logon or have forgotten your username and password please contact Karen. Membership Since the abolishment of membership fees the group s membership has increased considerably. The ALTG membership stands at 215 which has been a great effort. Thank you to all the members that are encouraging their colleagues to join the group. You can now apply online to become an ALTG member at Contact: Karen Lather ALTG Liaison Officer Phone: Karen@lungfoundation.com.au ALTG 04/003 - MATES Trial The primary objective of the MATES trial was to assess the effectiveness of thalidomide on time to progression. The trial also looked at progression-free survival, overall survival, toxicity, quality of life and the prognostic value of selected biomarkers. The MATES trial closed to recruitment in Australia on 17 December 2009, and globally on 31 December 2009 recruiting a total of 222 patients. In Australia 7 sites were activated recruiting 14 patients during the short recruitment period as follows: Calvary Mater Newcastle Hospital (NSW) - 1 Prince Charles Hospital (QLD) - 2 Sir Charles Gairdner Hospital (WA) - 6 Royal North Shore Hospital (NSW) - 5 Royal Prince Alfred Hospital - 0 Nepean Cancer Care Centre - 0 Flinders Medical Centre - 0 Efforts will now focus on collection of CRFs and close-out of sites. Study Chair: Nick Pavlakis pavlakis@med.usyd.edu.au CTC Trial Coordinator: Julia Hoffman MATES@ctc.usyd.edu.au

3 Page 3 ALTG 04/008 - ANTS Study A randomised phase II study comparing cisplatin and docetaxel with or without cetuximab given as neoadjuvant therapy in patients with stage II and IIIA resectable non-small cell lung cancer. deciding whether to proceed with activation or to wait until after the protocol amendment. - SCG, Monash, RPA & RNS are waiting for the protocol amendment to be finalised. This trial, therefore, aims primarily to assess, in patients with stage II and IIIA NSCLC, the efficacy of cetuximab given as neoadjuvant therapy in conjunction with neoadjuvant cisplatin and docetaxel in a phase II setting. This assessment will be performed using a randomized phase II trial design in which some patients will be treated with neoadjuvant cisplatin and docetaxel only, in order to provide a comparison group for the cetuximab arm. Number of sites participating: - Austin is activated and has screened 7 patients. - Prince Charles is activated. Two patients have been registered to the trial. A monitoring visit has been scheduled for August 26, STV has received approval and TGA acknowledgement for this study. This site is Number of sites with patients: 0 Total number of enrolled patients: 2 Date of first patient s enrolment: 24/03/09 Additional comments or issues: A/Prof Mitchell is working on the protocol amendment while on sabbatical in the US. Austin Health and the Prince Charles Hospital are activated and will continue to recruit. Other sites are waiting on the protocol amendment before submitting or becoming activated. Contact: A/Prof Paul Mitchell Tel: (03) paul.mitchell@austin.org.au A/Prof Martin Stocker CTC Clinical Lead Tel: stockler@med.usyd.edu.au Mamta Bagia ALTG/CTC Research Fellow Tel: mamta.bagia@ctc.usyd.edu.au Baerin Houghton ALTG/CTC Research Fellow Tel: baerin.houghton@ctc.usyd.edu.au ALTG 06/003 - NITRO Trial NITRO: A Phase III, randomised trial of adding nitroglycerin to first line chemotherapy for advanced non small cell lung cancer. The NITRO trial has been open since May 2009 and there are 9 sites activated, with 47 patients enrolled: The Prince Charles Hospital: 12 Royal Perth Hospital: 7 Coffs Harbour Health Campus: 13 Tamworth Hospital: 0 Armidale Hospital: 0 The Alfred Hospital: 2 Prince of Wales Hospital: 2 Port Macquarie Base Hospital: 6 Nepean Cancer Care Centre: 5 ALTG 09/001 - BR29 Trial A double blind randomised trial of cediranib versus placebo in patients receiving paclitaxel/carboplatin chemotherapy for the treatment of advanced or metastatic non small cell lung cancer. The first BR.29 site was opened on June 17 last year and since then, a further 8 sites have been activated. Recruitment currently stands at 43 patients. Activated Sites RPA NSW (17) Southern Medical Day Care Centre NSW (8) Peter MacCallum Cancer Centre Vic (5) 4 sites have received local Ethics Committee approval and are awaiting activation St John of God, Subiaco Royal Prince Alfred Hospital Royal Hobart Hospital Nambour Hospital The protocol amendment incorporating Maintenance treatment, and the use of Pemetrexed / platinum as one of the four chemotherapy regimens will be submitted before the end of June. Study Chair: Andrew Davidson andrew.davidson@health.wa.gov.au CTC Trial Coordinator: Nat Galbraith nitro@ctc.usyd.edu.au Sir Charles Gairdner Hospital WA (3) Liverpool Hospital NSW (3) Nambour Hospital Qld (5) Geelong Hospital Vic (1) St Vincent s Hospital Vic (1) Flinders Medical Centre SA It is hoped that an additional 6 sites will be activated soon to help boost the rate of recruitment. Study Chair: Ben Solomon ben.solomon@petermac.org CTC Trial Coordinator: Shona Silvester Eric Tsobanis CTC Assoc. Program Mgr Tel: eric.tsobanis@ctc.usyd.edu.au Shona Silvester CTC Trial Coordinator Tel: shona.silvester@ctc.usyd.edu.au Prunella Blinman CTC PhD Student Tel: prunella.blinman@ctc.usyd.edu.au Helen Taylor CTC Trial Coordinator/ Monitor Tel: Helen.taylor@ctc.usyd.edu.au Natalie Galbraith CTC Trial Coordinator Tel: natalie.galbraith@ctc.usyd.edu.au Michell Cummins CTC Trial Coordinator Tel: michelle.cummins@ctc.usyd.edu.au Chris Brown CTC Statistician Tel: chris.brown@ctc.usyd.edu.au

4 Page 4 ALTG 04/009 - PACT in NSCLC Study Preferences for adjuvant chemotherapy in non-smallcell lung cancer: What makes it worthwhile to patients and their doctors? The PACT in NSCLC study aims to determine the benefits judged necessary to make ACT worthwhile for patients with resected NSCLC and for doctors, the factors influencing their preferences, and patients preferred and experienced involvement in decision making. The inclusion criteria for this study are as follows: 1. Stage I-III non-small cell lung cancer resected within the last 12 weeks 2. Referred to a participating medical oncologist for consideration of post-operative ACT 3. Able and willing and to complete study questionnaires 4. Written, informed consent The exclusion criteria are: 1. Evidence of distant metastatic disease 2. Previous chemotherapy for lung cancer There are 7 sites activated with 29 patients enrolled: Royal North Shore Hospital - 2 St Vincent s Hospital Melbourne - 12 The Prince Charles Hospital - 7 Nambour General Hospital - 2 Nepean Hospital - 4 The Canberra Hospital - 1 Coffs Harbour Hospital - 1 An additional 3 sites have local Ethics Committee approval and are awaiting activation: Sir Charles Gairdner Hospital Auckland Hospital Royal Prince Alfred Hospital Study Chair: Sue-Anne McLachlan Sue-Anne.MCLACHLAN@svhm.org.au CTC Trial Coordinator: Helen Taylor lung_pt_pact@ctc.usyd.edu.au CTC preferences studies coordinator Prunella Blinman ALTG 08/001 - Physical Activity in Lung Cancer trial (PAL) The PAL study aims to evaluate the effects of a structured physical activity program on fatigue and quality of life in people with non-resectable thoracic cancer (NSCLC, SCLC). Participants are randomised to receive an 8-week personalised physical activity and behavioural support program plus general health education materials, or to receive general health education materials only. Recruitment The study opened in July A total of 14 participants have been recruited from Concord (8) and RPA (6) hospital. New sites Approval for the conduct of the study at Westmead hospital was granted in April Approval for Prince of Wales and Calvary hospital in Sydney is being sought. Protocol changes Mesothelioma patients have been excluded from the study population. Contacts Dr Janette Vardy (PI) janette.vardy@sydney.edu.au Amber Parkes (Study coordinator) amber.parkes@sydney.edu.au Erena Wikaire (Research Fellow / Substudy coordinator) erena.wikaire@sydney.edu.au ALTG 09/006 - Unmet Needs In Lung Cancer Patients and Carers ALTG Research Fellow, Erena Wikaire, is conducting a sub-study of PAL entitled Caring for thoracic cancer caregivers: exploring psychological and supportive care needs. The sub-study is being conducted at Concord and RPA Hospital. Approval for POW hospital was granted in April Study Contacts Dr Janette Vardy (PI) janette.vardy@sydney.edu.au Amber Parkes (Study coordinator) amber.parkes@sydney.edu.au Erena Wikaire (Research Fellow / Carer Substudy coordinator) erena.wikaire@sydney.edu.au 8 caregivers of PAL participants have been recruited to date. Ethics approval for the inclusion of caregivers of non-pal participants and for bereaved caregivers was granted in February carers of people with lung cancer who are not on the PAL study have been recruited to date.

5 Page 5 ALTG 09/002 - BR26 BR-26 is a randomised, double-blind, placebo-controlled trial of PF-804, an orally available, potent, and highly selective irreversible small molecule inhibitor of the human epidermal growth factor receptor HER family of tyrosine kinases HER-1 (EGFR), HER-2 and HER-4, in patients with incurable stage IIIB/IV non-small cell lung cancer after failure of standard therapy for advanced or metastatic disease. This multicentre, international phase III trial is being coordinated by the National Cancer Institute of Canada Clinical Trials Group in collaboration with the NHMRC Clinical Trials Centre and Australasian Lung cancer Trials Group. The study has received Central Ethics Committee approval in New South Wales, and Royal Prince Alfred Hospital has received approval from their local governance. Royal Prince Alfred Hospital will be open to recruitment by the end of April. 3 other sites (Peninsula Oncology, Monash Medical Centre and Sir Charles Gairdner Hospital) have submitted the study to their Ethics Committees and the remaining eight sites should have submitted to Ethics / governance by the end of May. Study Chair: Michael Millward millward@cyllene.uwa.edu.au CTC Trial Coordinator: Nat Galbraith BR.26@ctc.usyd.edu.au ALTG 09/004 - B2P2M2 B2P2M2 is a single arm phase II trial of BNC105P as second line chemotherapy after pemetrexed and a platinum in patients with advanced malignant pleural mesothelioma. BNC105P is a novel, intravenous tubulin polymerase inhibitor with direct cytotoxicity and vascular disrupting effects, which has shown some activity against MPM in a recent phase I trial. It was developed by Bionomics Ltd, an Australian biotech company. The trial will be coordinated by the NHMRC Clinical Trials Centre under the auspices of the Australasian Lung cancer Trials Group. Primary Objective: To determine the objective tumour response rate (CR or PR) according to RECIST modified for mesothelioma Key Eligibility Criteria: Inclusion criteria Histologically or cytologically proven diagnosis of MPM. Progression after first line chemotherapy with pemetrexed and a platinum (cisplatin and/or carboplatin). Performance status of ECOG 0-1. Exclusion Criteria Any prior chemotherapy other than pemetrexed and a platinum compound. Untreated and/or uncontrolled cardiovascular conditions and/or symptomatic cardiac dysfunction Poorly controlled hypertension: systolic BP >150 or diastolic BP >100 mmhg. Secondary Objectives: Progression free-survival (PFS progression or death), Treatment duration (TD time from first dose to last dose), Adverse events (grades 1-5) according to NCI CTCAE v 4.0, Effects on health-related quality of life, Changes in lung function (FEV 1 and FVC), Overall survival (OS death from any cause). Trial Schema: All patients will be given BNC105P 16 mg/m 2 given intravenously on days 1 and 8 of 21 day cycles repeated until progression or prohibitive toxicity. 60 patients will be recruited to the study over a 24 month recruitment period. The study has received central ethical approval in NSW and local ethics submissions are currently underway for 12 sites around Australia. An Investigator s meeting was held on 26 March 2010, and the first sites are expected to be activated shortly. Study Chair: Anna Nowak anowak@meddent.uwa.edu.au CTC Trial Coordinator: Michelle Cummins b2p2m2@ctc.usyd.edu.au

6 Page 6 ALTG 09/008 MESORADS Trial A phase II single arm study of high dose radiotherapy in the palliation of malignant pleural mesothelioma, using 18 F-FDG PET scan analysis The trial seeks to provide evidence that radiotherapy delivered with improved technologies and using strict normal tissue dose constraints can safely deliver doses of 60 Gy to symptomatic tumour masses. Assessment of tumour response is by PET scans obtained before and 3 months after radiotherapy. Trial approved for further development by TROG. Eligibility criteria All stages of malignant pleural mesothelioma with symptomatic and measurable disease that is 18 F-FDG-avid. Radiotherapy volume not to exceed one hemithorax. Patients with local progression after surgery and/or chemotherapy are acceptable PI: Dr Malcolm Feigen malcolm.feigen@austin.org.au Primary objectives Symptom palliation, pain control, reduction in 18 FDG PET scan activity TROG CHISEL (ALTG 09/005) CHISEL is a Phase 3 randomised trial of highly Conformal Hypofractionated Image guided Stereotactic radiotherapy versus conventional fractionated radiotherapy for inoperable Early stage non-small cell Lung cancer. The hypothesis is that hypofractionated image guided radiotherapy for peripherally located inoperable T1 and T2a non-small cell lung cancer using a dose of 54Gy in 3 fractions results in superior control of disease at the primary site compared with standard care consisting of conventionally fractionated radiotherapy of 66Gy in 33 fractions given over six weeks. The primary end point is time to local failure, with secondary end points being survival, toxicity and quality of life. To be eligible patients require histological or cytologic proof of non-small cell lung cancer. They have to have Stage I (T1, T2a N0) disease confirmed by FDG PET and a performance status of ECOG 0-1. They need to be inoperable or refuse surgery, and the lesion should have a peripheral location. Tumours which are closer than 2cm to the bifurcation of the lobar bronchus or within 1cm of the mediastinum or the chest wall are excluded. Patients having induction chemotherapy are also ineligible. Sites will be credentialled individually in relation to their technical capacity to deliver treatment before they can start enrolling patients on this study. There are four main requirements: 1) patient immobilisation; 2) an ability to account for tumour motion which will normally be 4D CT; 3) a treatment planning system which accounts for lateral scatter; 4) and image guidance in the treatment room. The statistics are based on a local failure rate at two years of 30% in the conventional arm and 10% in the hypofractionated arm, which will require 105 patients to be recruited over three years. The current status of the trial is that Peter MacCallum East Melbourne has been credentialled by an independent external credentialing team in December 2009 and the first patient was randomised at the end of end of December A number of sites have submitted to and are waiting on ethics (a NEAF application has been completed and is available). CHISEL is now co-badged with the Australian Lung Trials Group with TROG as the lead group. A facility questionnaire has been mailed out to sites expressing interest in participating in the Trial. Once the questionnaire has been completed and the Trial Physicist (Thomas Kron) has assessed the site as capable of delivering the experimental treatment arrangements will be made for a credentialling site visit. CHISEL is funded by Cancer Australia for three years ($260,000). This provides $500 capitation per patient and $800 for a PET scan if this is required to confirm progression. It also covers costs of credentialing. A separate application for funding has been submitted for New Zealand sites thanks to Scott Babington. Any further enquiries regarding this Trial should be directed to the principal investigator, David Ball, at david.ball@petermac.org or the central trial coordinator, Joanne Dean (joanne.dean@petermac.org).

7 Page 7 Australian Lung Cancer Conference (ALCC) October 2010 Emerging Evidence The Australian Lung Foundation s 3 rd Australian Lung Cancer Conference will be the largest gathering in Australia of clinicians, researchers, nurses, allied health professionals and consumers all of whom with a common focus - Lung Cancer. The conference will attract over 300 delegates from around Australia, New Zealand and the rest of the world. It gives us great pleasure to invite you to participate in this conference which is going to be held in the beautiful city of Melbourne from Thursday 7 October Saturday 9 October This Conference is a superb opportunity for lung cancer professionals to share the most upto-date research on science and treatment advances. Lung cancer specialists from a wide range of disciplines will participate in the scientific program with the latest basic science and clinical data. Leading national and international lung cancer clinicians and researchers will contribute to the program, together with special workshops (medical and nursing) and an ALTG meeting. Registration Registration is now open. We urge you to register online early to avoid disappointment. Early bird registration closes 13 August. Call for Abstracts The Scientific Committee invites you to submit abstracts for consideration for the program at the conference. All abstracts will be reviewed by a panel of experts who will grade them for inclusion into the oral communication and poster sessions. Submission deadline for Abstracts - 16 July International Speakers Four international speakers have been confirmed to date - Prof David Gandarra Medical Oncologist, San Francisco USA; Prof Fred Hirsch, Pulmonologist, Colorado USA; Prof Mark Socinski, Medical Oncologist, North Carolina USA and Ms Michele O Brien, Thoracic Nurse, Minnesota USA. Lung Cancer Nurses/ Allied Health Workshop - 6 October, 10.00am pm This workshop will include nurse-oriented updates/ knowledge transfer in the direction of nurses and nurse-nurse level education to target both existing nurses and nurses new to the lung cancer/ Mesothelioma area. The broader aim is to foster the community that is developing amongst nurses working in lung cancer. This workshop is open to nurses and allied health workers who have an interest in lung cancer and either have a vast interest in, or who work/care for patients with lung cancer/mesothelioma and their families. Important Dates Abstract Submissions Open 1 February 2010 Registration Open 1 March 2010 Abstract Submission Deadline 16 July 2010 Notification of Abstract Acceptance 6 August 2010 Early Registration Deadline 13 August 2010 Nurse Satellite Workshop 6 October 2010 Conference Official Opening 7 October 2010 Lung Cancer Biomarkers Satellite Symposium - 6 October, 12.30pm pm Targeted therapy and personalised medicine is becoming a real possibility to benefit our patients with lung cancer. Effective biomarker based medicine is a new paradigm, requiring coordination and integrating the skills of the diagnostic thoracic physician, interventional radiologist, clinical and molecular pathologist, laboratory scientist, surgeon, radiation and medical oncologists together with the rest of the multidisciplinary team. In this Workshop, expert researchers and clinicians from Australia and overseas will work with delegates in an interactive session to share knowledge, gain ideas on how to translate the explosion in biomarker medicine to the clinic to benefit for our patients in a cost-effective way. We invite you to join us for this satellite workshop and to contribute to the advancement of targeted therapies for lung cancer in clinical practice. Numbers will be capped to ensure adequate interaction - first come first served! Registration Fees Early (before 13 Aug) Standard Full Registration - Lung Foundation Member $510 $580 Full Registration - Lung Foundation Non Member $560 $630 Full Registration - Nurse/ Allied Health/ Student/ Trainee/ Non Medical $400 $470 Nurse Registration & Nurse Satellite Workshop $510 $580 Nurse Satellite Workshop Only (6 October) $160 $160 Day Registration - Single Day $225 $225 Day Registration - Two Day $425 $425

8 The Australasian Lung cancer Trials Group (ALTG) is Australia and New Zealand's lung and thoracic cancer clinical research group. The ALTG is a multi-disciplinary organization dedicated to reducing the incidence, morbidity and mortality of lung and thoracic cancer and improving the quality of life of lung and thoracic cancer patients in Australia and New Zealand through the coordination and facilitation of high quality clinical research. The ALTG collaborates with a number of organizations including the NHMRC Clinical Trials Centre (CTC) and Peter MacCallum Cancer Centre. Both of these groups are leaders in Australia for the design, conduct, analysis and publication of oncology clinical trials, including working with both Australia and international collaborative groups. The specific objectives of the ALTG are: To facilitate participation in the development, conduct, evaluation, reporting of clinical trials in lung and thoracic cancer. To promote the use of clinical trials in evaluating new treatments and management approaches for lung and thoracic cancer. We re on the Web! Business Address: Australasian Lung cancer Trials Group c/o The Australian Lung Foundation 44 Brookes Street Bowen Hills QLD 4006 Mailing Address: Australasian Lung cancer Trials Group c/o The Australian Lung Foundation PO Box 847 Lutwyche QLD 4030 Telephone: 61 (0) Fax: 61 (0) Karen@lungfoundation.com.au The ALTG is generously supported through unrestricted educational grants from the following companies: