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Sponsored by: |
National Cancer Institute of Canada |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00795340 |
RATIONALE: Cediranib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether cediranib is more effective than a placebo when given together with paclitaxel and carboplatin in treating patients with non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying how well cediranib works when given together with paclitaxel and carboplatin in treating patients with stage IIIB or stage IV non-small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: carboplatin Drug: cediranib maleate Drug: paclitaxel Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Official Title: | A Double Blind Randomized Trial of Cediranib Versus Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer |
Estimated Enrollment: | 750 |
Study Start Date: | November 2008 |
Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
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Drug: carboplatin
Given IV
Drug: cediranib maleate
Given orally
Drug: paclitaxel
Given IV
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Arm II: Placebo Comparator
Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.
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Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
Drug: placebo
Given orally
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified by gender, center, disease stage (IIIB vs IV), weight loss (< 5% vs 5-10% vs unknown), and prior adjuvant chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Treatment in both arms repeats every 21 days for 4 to 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, on day 1 of each course, and periodically thereafter.
After completion of study therapy, patients are followed every 12 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically* confirmed non-small cell carcinoma of the lung
Measurable disease, defined as at least 1 measurable lesion ≥ 20 mm by x-ray, ultrasound, conventional CT scan, or physical exam or ≥ 10 mm by spiral CT scan (in the first 260 patients randomized**)
No untreated brain or meningeal metastases
PATIENT CHARACTERISTICS:
No untreated and/or uncontrolled cardiovascular conditions and/or symptomatic cardiac dysfunction including any of the following:
No clinically relevant hemoptysis (> 5 mL fresh blood) within the past 4 weeks
No documented weight loss > 10% within the past 3 months
PRIOR CONCURRENT THERAPY:
No prior anti-angiogenic therapy (e.g., bevacizumab, cediranib, AZD6474, PTK/ZK, sunitinib malate, or other agents considered angiogenesis inhibitors by National Cancer Institute of Canada Clinical Trials Group [NCIC CTG] for any indication)
At least 12 months since prior adjuvant chemotherapy for completely resected disease
Study ID Numbers: | CDR0000618671, CAN-NCIC-BR29 |
Study First Received: | November 20, 2008 |
Last Updated: | December 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00795340 |
Health Authority: | Unspecified |
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent non-small cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Paclitaxel Lung Neoplasms Lung Diseases |
Carboplatin Carcinoma, Non-Small-Cell Lung Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Mitosis Modulators Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |