Cediranib, Paclitaxel, and Carboplatin in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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.
Drug: cediranib maleate
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Overall Survival [ Time Frame: at every 3 months visit throughout trial, a median of 13.1 months. ] [ Designated as safety issue: No ]Medians of survival time, and their confidence intervals.
- Progression-free Survival [ Time Frame: at every 3 months visit throughout trial, a median of 12 months ] [ Designated as safety issue: No ]Medians of PFS and their confidence intervals by arm
- Objective Tumor Response as Assessed by RECIST Criteria v1.1. [ Time Frame: Every 6 weeks at the end of every 2 cycles during protocol treatment and every 12 weeks after protocol treatment until progression. ] [ Designated as safety issue: No ]Every 6 weeks at the end of every 2 cycles during protocol treatment and every 12 weeks after protocol treatment until progression.
|Study Start Date:||November 2008|
|Study Completion Date:||January 2014|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Experimental: Arm I Cediranib
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.
Given IVDrug: cediranib maleate
Given orallyDrug: paclitaxel
Placebo Comparator: Arm II Placebo
Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.
Given IVDrug: paclitaxel
Given IVOther: placebo
- To compare overall survival of patients with stage IIIB-IV non-small cell lung cancer treated with cediranib vs placebo administered in combination with paclitaxel and carboplatin.
- To compare the progression-free survival of patients treated with these regimens.
- To compare the objective response rates in patients treated with these regimens.
- To estimate time to response and response duration in patients treated with these regimens.
- To evaluate the nature, severity, and frequency of toxicities, including hemorrhage and hemoptysis, in patients treated with these regimens.
- To compare the pharmacokinetics of paclitaxel between the two arms in a subset of enrolled patients
- To compare the quality of life of patients treated with these regimens.
- To determine the incremental cost effectiveness and cost utility ratios for these regimens.
- To correlate the expression of tissue markers (at diagnosis) with outcomes and response in an exploratory fashion 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.
- Arm I: 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.
- Arm II: Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795340
|Instituto Nacional de Cancer (INCA)|
|Rio de Janeiro, Brazil, CEP20231-050|
|Instituto de Cancer Arnaldo Vieira de Carvalho|
|Sao Paulo, Brazil, 01224-010|
|Tom Baker Cancer Centre|
|Calgary, Alberta, Canada, T2N 4N2|
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|BCCA - Abbotsford Centre|
|Abbotsford, British Columbia, Canada, V2S 0C2|
|BCCA - Fraser Valley Cancer Centre|
|Surrey, British Columbia, Canada, V3V 1Z2|
|BCCA - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Juravinski Cancer Centre at Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8V 5C2|
|Cancer Centre of Southeastern Ontario at Kingston|
|Kingston, Ontario, Canada, K7L 5P9|
|London Regional Cancer Program|
|London, Ontario, Canada, N6A 4L6|
|Ottawa Health Research Institute - General Division|
|Ottawa, Ontario, Canada, K1H 8L6|
|Algoma District Cancer Program|
|Sault Ste. Marie, Ontario, Canada, P6B 0A8|
|Niagara Health System|
|St. Catharines, Ontario, Canada, L2R 7C6|
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G 1X5|
|Univ. Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Windsor Regional Cancer Centre|
|Windsor, Ontario, Canada, N8W 2X3|
|McGill University - Dept. Oncology|
|Montreal, Quebec, Canada, H2W 1S6|
|Allan Blair Cancer Centre|
|Regina, Saskatchewan, Canada, S4T 7T1|
|University Institute of Cardiology and|
|Quebec, Canada, G1V 4G5|
|Study Chair:||Scott A. Laurie, MD, FRCPC||Ottawa Regional Cancer Centre|