A Randomized Phase II Trial of Paclitaxel-Carboplatin or Gemicitabine-Cisplatin in ECOG Performance Status 2 Non-Small Cell Lung Cancer Patients
- Compare overall survival, response rate, and time to progression of patients with
non-small cell lung cancer treated with paclitaxel and carboplatin versus gemcitabine
- 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
PROJECTED ACCRUAL: Approximately 40-90 patients (20-45 per arm) will be accrued for this
study within 12 months.
Allocation: Randomized, Primary Purpose: Treatment
Corey J. Langer, MD
Fox Chase Cancer Center
United States: Federal Government
|Emory University Hospital - Atlanta||Atlanta, Georgia 30322|
|Milton S. Hershey Medical Center||Hershey, Pennsylvania 17033|
|CCOP - Northern New Jersey||Hackensack, New Jersey 07601|
|MBCCOP - University of New Mexico HSC||Albuquerque, New Mexico 87131|
|CCOP - Scott and White Hospital||Temple, Texas 76508|
|CCOP - St. Vincent Hospital Cancer Center, Green Bay||Green Bay, Wisconsin 54301|
|CCOP - Oklahoma||Tulsa, Oklahoma 74136|
|Cancer Institute of New Jersey||New Brunswick, New Jersey 08901|
|James P. Wilmot Cancer Center||Rochester, New York 14642|
|Iowa Methodist Medical Center||Des Moines, Iowa 50309|
|Mercy Medical Center||Des Moines, Iowa 50314|
|Iowa Lutheran Hospital||Des Moines, Iowa 50316-2301|
|Alegent Health-Midlands Community Hospital||Papillion, Nebraska 68128-4157|