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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 083580
ACTR Number: ACTRN12609000247279
Trial Status: Registered
Date Submitted: 9/02/2009
Date Registered: 12/05/2009

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Public title: BR.29. 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.
ANZCTR registration title: BR.29. A double bind randomized trial of cediranib versus placebo in patients receiving paclitaxel/carboplatin chemotherapy for the treatment of advanced or metastatic non-small cell lung cancer.
Secondary ID:NCT00795340 - Issued by clinicaltrials.gov. A service of the US National Institute of Health. 
UTN:
Trial acronym:

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Health condition(s) or problem(s) studied:
Advanced or metastatic non-small cell lung cancer 
Condition category: Condition code:
Cancer Lung - Non small cell 

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Description of intervention(s) / exposure: All subjects randomised to receive cediranib will receive paclitaxel(200mg/m2)/carboplatin Area Under the Curve 6 (AUC6) treatment intraveneously, once every 3 weeks, in combination with daily cediranib (20mg delivered orally) for a maximum of 6 cycles (Each cycle should last 21 days. There are no breaks between cycles). The number of cycles administered will be determined by the treating physician. Following this, cediranib will continue to be administered daily until unmanageable toxicity or disease progression.
Intervention code:Treatment: drugs 
Comparator / control treatment: All subjects randomised to the placebo arm will receive paclitaxel(200mg/m2)/carboplatin(AUC6) treatment intraveneously, once every 3 weeks, in combination with daily placebo (oral sugar tablet) for a maximum of 6 cycles (Each cycle should last 21 days. There are no breaks between cycles). The number of cycles administered will be determined by the treating physician. Following this, oral dose placebo will continue to be administered daily until unmanageable toxicity or disease progression.
Control group: Placebo

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Primary outcome:Overall survival. All randomised patients will continue to be followed until death. 
Timepoint:3 years post-inital treatment cycle and then yearly until death. 
Secondary outcome 1:Comparison of progression-free survival between arms. Progression-free will be determined according to the Response Evaluation Criteria In Solid Tumors (RECIST) V1.1 criteria. 
Timepoint:3 years post-initial treatment cycle. 
Secondary outcome 2:Objective response rates as determined using the RECIST V1.1 criteria. 
Timepoint:3 years post-initial treatment cycle. 
Secondary outcome 3:Time to response (the time between first dose of study drug and positive tumour response as measured by RECIST V1.1) and response duration (time between first positive response and first sign of disease progression as measured by RECIST V1.1). 
Timepoint:3 years post-initial treatment cycle. 
Secondary outcome 4:Evaluation of the nature, severity and frequency of toxicities between the two arms (as monitored by health care professionals) 
Timepoint:3 years post-initial treatment cycle. 
Secondary outcome 5:Comparison of quality of life (assessed using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) and Quality of Life Questionnaire Lung Cancer Module (QLQ-C30) questionnaires), cost-effectiveness of each arm (measured using the Health Utilities Index (HU13), and to correlate the expression of tissue markers (at diagnosis) with outcomes and response (using tissue collected in the optional tissue banking section of the study). 
Timepoint:3 years post-initial treatment cycle. 

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Key inclusion criteria: -Histologically or cytologically confirmed non-small cell carcinoma of the lung.
-Stage IIIB or IV disease - Measurable disease, defined as at least 1 measurable lesion – tumour lesion: = 20 mm by chest x-ray, physical exam or = 10 mm by spiral Computerised Tomography (CT) scan; = 15mm for nodes (in the first 260 patients randomized). NOTE: Measurable or non-measurable disease allowed after the first 260 patients.
-Adequate haematological, renal and hepatic function as defined in the
protocol
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Must be fit for combined modality treatment.
- Sufficiently fluent and willing to complete quality-of-life questionnaires.
- Recovered from all prior therapy
- No prior chemotherapy for metastatic or recurrent disease (Prior cox-2 inhibitors in standard doses allowed)
- At least 12 months since prior adjuvant chemotherapy for completely resected disease(Combined chemotherapy/radiotherapy regimens for locally advanced stage IIIB disease not allowed)
Minimum Age: 18 Years
Maximum Age: No limit
Gender: Both males and females
Healthy volunteers? No
Key exclusion criteria: - Untreated brain or meningeal metastases (Patients with treated and radiologic or clinical evidence of stable brain metastases, with no evidence of cavitation or hemorrhage in the brain lesion, are eligible provided the metastases are asymptomatic and do not require corticosteroids) - Appreciable cavitation in central thoracic lesions - Other malignancy within the past 5 years, except in situ cancer, basal cell or squamous cell skin cancer, or malignancy cured by definitive prior therapy alone (e.g., surgery) and continuously disease-free for at least 5 years - Mean QTc with Bazett correction > 470 msec in screening Electrocardiogram (ECG) - History of familial long QT syndrome - Untreated and/or uncontrolled cardiovascular conditions and/or symptomatic cardiac dysfunction including any of the following: Unstable angina, congestive heart failure, myocardial infarction within the past year, cardiac ventricular arrhythmias requiring medication, history of second or third degree atrioventricular conduction defects - Left Ventricular Ejection Fraction (LVEF) > 50% in patients with significant cardiac history, even if controlled - Resting Blood Pressure (BP) consistently > 150 mm Hg systolic and/or > 100 mm Hg diastolic - Poorly controlled hypertension - History of labile hypertension or poor compliance with anti-hypertensive medication - Overt bleeding (> 30 mL bleeding/episode) from any site within the past 3 months - Clinically relevant hemoptysis (> 5 mL fresh blood) within the past 4 weeks (Flecks of blood in sputum allowed) - Active or uncontrolled infections, or serious illnesses or medical conditions which would not permit the patient to be treated according to the study - Prior allergic reactions to drugs containing Cremophor EL (R). - Inflammatory bowel disease (e.g., Crohn disease or ulcerative colitis) - Documented weight loss > 10% within the past 3 months (Patients with weight loss 5-10% or whose weight loss status is unknown are eligible provided serum albumin levels are = 30 g/L) - Peripheral neuropathy > grade 1 - Pregnant or nursing - Prior anti-angiogenic therapy - At least 21 days since prior radiotherapy

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Study type: Interventional
Purpose of the study: Treatment
Allocation to intervention: Randomised controlled trial
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures): Enrolment and randomisation will be performed by each site locally using a central randomisation system (Mango).
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation): Minimisation
Masking / blinding: Blinded (masking used)
Who is/are masked/blinded: The people receiving the treatment/s
 The people administering the treatment/s
Assignment: Parallel
Other design features (specify):
Type of endpoint(s): Safety/efficacy

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Phase Phase 3
Anticipated or actual date of first participant enrolement: 1/04/2009
Target sample size: 750
Recruitment status: Open to recruitment

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Funding source 1:Other Collaborative groups 
Name:National Cancer Institute Canada 
Address:Queen's University 10 Stuart Street Kingston, ON K7L 3N6 
Country:Canada 
Funding source 2:Commercial sector/Industry 
Name:Astra Zeneca 
Address:1004 Middlegate Road Mississauga, Ontario L4Y 1M4 
Country:Canada 
Primary sponsor: Government funding body e.g. Department of Health
Name: National Health and Medical Research Council (NHMRC) Clinical Trials Centre
Address: 6-10 Mallett St CAMPERDOWN NSW 2050
Country: Australia
Secondary sponsor:None 
Name: 
Address: 
Country: 
Other collaborator 1:Other Collaborative groups 
Name:National Cancer Institute Canada 
Address:Queen's University 10 Stuart Street Kingston, ON K7L 3N6 
Country:Canada 
Other collaborator 2:Other Collaborative groups 
Name:Australasian Lung Cancer Trials Group 
Address:PO Box 847 Lutwyche QLD 4030 
Country:Australia 

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Has the study received approval from at least one ethics committee? Yes
Ethics Committee name:NSW Cancer Institute Ethics Committee 
Address:PO Box 41 Alexandria NSW 1435 
Country:Australia 
Date of approval:19/01/2009 
HREC Number:2008C/11/074 
Countries of recruitment:Australia 
Postcode:Outside Australia 
Canada 
New Zealand 
Brief summary: This study looks at treatment with the drug Cediranib, in patients who have advanced or metastatic lung cancer.
Who is it for? You can join this study if you have advanced or metastatic non-small cell lung cancer.
Trial details: Participants will be randomly divided into two groups. Both groups will receive intraveneous chemotherapy treatment. The first group will also receive the new drug Cediranib. The second group will receive a dummy (placebo) treatment. Both groups will receive the chemotherapy drugs Paclitaxel and Carboplatin. This will be administered intraveneously once every 3weeks. The number of cycles will be determined by the physician. No more than 6 cycles will be administered. The group receiving the drug Cediranib will receive a daily dose of 20mg, administered orally, in addition to the chemotherapy treatment. The group receiving the dummy treatment will receive a daily dose, administered orally, in addition to the chemotherapy treatment.
The study aims to see whether combining the drug Cediranib with chemotherapy treatment, compared with chemotherapy alone, improves overall survival rates.
The study also looks at quality of life.
Trial website:
Presentations / publication list:

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Contact person for public queries
Name: Shona Silvester
Address: National Health and Medical Research Council (NHMRC) Clinical Trials Centre University of Sydney Locked Bag 77 Camperdown NSW 1450
Country: Australia
Tel: +61 2 9562 5301
Fax:
Email: shona.silvester@ctc.usyd.edu.au

Contact person for scientific queries
Name: Dr. Benjamin Solomon
Address: Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne VIC 3002
Country: Australia
Tel: +61 3 9656 1697
Fax:
Email: ben.solomon@petermac.org

Contact person responsible for updating information
Name: Shona Silvester
Address: National Health and Medical Research Council (NHMRC) Clinical Trials Centre
University of Sydney
Locked Bag 77
Camperdown NSW 1450
Country: Australia
Tel: +61 2 9562 5301
Fax:
Email: shona.silvester@ctc.usyd.edu.au
   
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