Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000247279
Ethics application status
Approved
Date submitted
9/02/2009
Date registered
12/05/2009
Date last updated
10/12/2018
Date data sharing statement initially provided
10/12/2018
Type of registration
Prospectively registered

Titles & IDs
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.
Scientific 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 [1] 800 0
NCT00795340 - Issued by clinicaltrials.gov. A service of the US National Institute of Health.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced or metastatic non-small cell lung cancer 4285 0
Condition category
Condition code
Cancer 4516 4516 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
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 [1] 4016 0
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

Outcomes
Primary outcome [1] 5394 0
Overall survival. All randomised patients will continue to be followed until death.
Timepoint [1] 5394 0
3 years post-inital treatment cycle and then yearly until death.
Secondary outcome [1] 9064 0
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 [1] 9064 0
3 years post-initial treatment cycle.
Secondary outcome [2] 9065 0
Objective response rates as determined using the RECIST V1.1 criteria.
Timepoint [2] 9065 0
3 years post-initial treatment cycle.
Secondary outcome [3] 9066 0
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] 9066 0
3 years post-initial treatment cycle.
Secondary outcome [4] 9067 0
Evaluation of the nature, severity and frequency of toxicities between the two arms (as monitored by health care professionals)
Timepoint [4] 9067 0
3 years post-initial treatment cycle.
Secondary outcome [5] 9068 0
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 [5] 9068 0
3 years post-initial treatment cycle.

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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).
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?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Safety concerns
Date of first participant enrolment
Anticipated
1/04/2009
Actual
24/06/2009
Date of last participant enrolment
Anticipated
Actual
14/12/2010
Date of last data collection
Anticipated
Actual
30/06/2011
Sample size
Target
750
Accrual to date
Final
306
Recruitment in Australia
Recruitment state(s)
NSW,VIC,QLD,SA,WA
Recruitment outside Australia
Country [1] 1560 0
Canada
State/province [1] 1560 0
Country [2] 1561 0
New Zealand
State/province [2] 1561 0

Funding & Sponsors
Funding source category [1] 4464 0
Other Collaborative groups
Name [1] 4464 0
National Cancer Institute Canada
Country [1] 4464 0
Canada
Funding source category [2] 4465 0
Commercial sector/Industry
Name [2] 4465 0
Astra Zeneca
Country [2] 4465 0
Canada
Primary sponsor type
Government body
Name
National Health and Medical Research Council (NHMRC) Clinical Trials Centre
Address
6-10 Mallett St
CAMPERDOWN
NSW
2050
Country
Australia
Secondary sponsor category [1] 4023 0
None
Name [1] 4023 0
Address [1] 4023 0
Country [1] 4023 0
Other collaborator category [1] 559 0
Other Collaborative groups
Name [1] 559 0
National Cancer Institute Canada
Address [1] 559 0
Queen's University
10 Stuart Street
Kingston, ON K7L 3N6
Country [1] 559 0
Canada
Other collaborator category [2] 560 0
Other Collaborative groups
Name [2] 560 0
Australasian Lung Cancer Trials Group
Address [2] 560 0
PO Box 847 Lutwyche QLD 4030
Country [2] 560 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6523 0
NSW Cancer Institute Ethics Committee
Ethics committee address [1] 6523 0
Ethics committee country [1] 6523 0
Australia
Date submitted for ethics approval [1] 6523 0
24/10/2008
Approval date [1] 6523 0
19/01/2009
Ethics approval number [1] 6523 0
2008C/11/074

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29259 0
Address 29259 0
Country 29259 0
Phone 29259 0
Fax 29259 0
Email 29259 0
Contact person for public queries
Name 12506 0
Eric Tsobanis
Address 12506 0
National Health and Medical Research Council (NHMRC) Clinical Trials Centre University of Sydney Locked Bag 77 Camperdown NSW 1450
Country 12506 0
Australia
Phone 12506 0
+61 2 9562 5000
Fax 12506 0
+61 2 9562 5094
Email 12506 0
[email protected]
Contact person for scientific queries
Name 3434 0
Dr. Benjamin Solomon
Address 3434 0
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne VIC 3002
Country 3434 0
Australia
Phone 3434 0
+61 3 9656 1697
Fax 3434 0
Email 3434 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.