Comparison of Two Combination Chemotherapy Regimens in Treating Non-small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00006004
- Lead Sponsor
- Eastern Cooperative Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for treating non-small cell lung cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have non-small cell lung cancer.
- Detailed Description
OBJECTIVES:
* Compare overall survival, response rate, and time to progression of patients with non-small cell lung cancer treated with paclitaxel and carboplatin versus gemcitabine and cisplatin.
* Compare the toxicities of each of these 2 regimens in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to weight loss in the past 6 months (less than 5% vs at least 5%) and disease stage (stage IIIB with pleural or pericardial effusion or pleural implants vs stage IV/recurrent). Patients are randomized to one of two treatment arms.
* Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 15-30 minutes on day 1.
* Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by cisplatin IV over 1 hour on day 1 only.
Treatment continues in both arms every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 40-90 patients (20-45 per arm) will be accrued for this study within 12 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
Instituto de Enfermedades Neoplasicas
🇵🇪Lima, Peru
Mercy Medical Center
🇺🇸Des Moines, Iowa, United States
Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
Iowa Lutheran Hospital
🇺🇸Des Moines, Iowa, United States
Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
CCOP - Northern New Jersey
🇺🇸Hackensack, New Jersey, United States
San Juan City Hospital
🇵🇷San Juan, Puerto Rico
MBCCOP - University of New Mexico HSC
🇺🇸Albuquerque, New Mexico, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
🇺🇸Green Bay, Wisconsin, United States
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
Alegent Health-Midlands Community Hospital
🇺🇸Papillion, Nebraska, United States
James P. Wilmot Cancer Center
🇺🇸Rochester, New York, United States
CCOP - Oklahoma
🇺🇸Tulsa, Oklahoma, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States