Cediranib, Paclitaxel, and Carboplatin in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Registration Number
- NCT00795340
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* 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.
Secondary
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 306
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I Cediranib cediranib maleate 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 Placebo placebo Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I. Arm I Cediranib paclitaxel 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 Placebo carboplatin Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I. Arm II Placebo paclitaxel Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I. Arm I Cediranib carboplatin 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.
- Primary Outcome Measures
Name Time Method Overall Survival at every 3 months visit throughout trial, a median of 13.1 months. Medians of survival time, and their confidence intervals.
- Secondary Outcome Measures
Name Time Method Progression-free Survival at every 3 months visit throughout trial, a median of 12 months Medians of PFS and their confidence intervals by arm
Objective Tumor Response as Assessed by RECIST Criteria v1.1. Every 6 weeks at the end of every 2 cycles during protocol treatment and every 12 weeks after protocol treatment until progression. Every 6 weeks at the end of every 2 cycles during protocol treatment and every 12 weeks after protocol treatment until progression.
Trial Locations
- Locations (19)
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
BCCA - Fraser Valley Cancer Centre
🇨🇦Surrey, British Columbia, Canada
BCCA - Vancouver Cancer Centre
🇨🇦Vancouver, British Columbia, Canada
BCCA - Abbotsford Centre
🇨🇦Abbotsford, British Columbia, Canada
McGill University - Dept. Oncology
🇨🇦Montreal, Quebec, Canada
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
Algoma District Cancer Program
🇨🇦Sault Ste. Marie, Ontario, Canada
Instituto Nacional de Cancer (INCA)
🇧🇷Rio de Janeiro, Brazil
Instituto de Cancer Arnaldo Vieira de Carvalho
🇧🇷Sao Paulo, Brazil
Juravinski Cancer Centre at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Niagara Health System
🇨🇦St. Catharines, Ontario, Canada
University Institute of Cardiology and
🇨🇦Quebec, Canada
Ottawa Health Research Institute - General Division
🇨🇦Ottawa, Ontario, Canada
Univ. Health Network-Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston
🇨🇦Kingston, Ontario, Canada
London Regional Cancer Program
🇨🇦London, Ontario, Canada
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
Windsor Regional Cancer Centre
🇨🇦Windsor, Ontario, Canada