A Phase II Clinical Trial Evaluating Three Schedules Of ALIMTA Plus Gemcitabine As Frontline Chemotherapy For Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
- Compare the tumor response rates in patients with locally advanced or metastatic
non-small cell lung cancer treated with 3 different schedules of pemetrexed disodium
- Compare the duration of response, time to progressive disease, time to treatment
failure, and survival time in patients treated with these regimens.
- Compare the quantitative and qualitative toxic effects of these regimens in these
OUTLINE: This is a randomized, open-label study. Patients are stratified according to stage
of disease (IIIB vs IV) and ECOG performance status (0 vs 1). Patients are randomized to one
of three treatment arms.
- Arm I: Patients receive pemetrexed disodium IV over 10 minutes on day 1 followed by
gemcitabine IV over 30 minutes on days 1 and 8.
- Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by
pemetrexed disodium IV over 10 minutes on day 1.
- Arm III: Patients receive gemcitabine IV over 30 minutes on day 1 and pemetrexed
disodium IV over 10 minutes followed by gemcitabine IV over 30 minutes on day 8.
Treatment repeats every 21 days for 2 courses in the absence of disease progression or
unacceptable toxicity. Patients with stable or responding disease may receive up to 6
additional courses of therapy.
Patients are followed every 2 months for 1 year and then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 180 patients (60 per treatment arm) will be accrued for this
study within 20 months.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Alex A. Adjei, MD, PhD
United States: Federal Government
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|CCOP - Ann Arbor Regional||Ann Arbor, Michigan 48106|
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|CCOP - Missouri Valley Cancer Consortium||Omaha, Nebraska 68131|
|CCOP - Illinois Oncology Research Association||Peoria, Illinois 61602|
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|CCOP - Iowa Oncology Research Association||Des Moines, Iowa 50309-1016|
|CCOP - Metro-Minnesota||Saint Louis Park, Minnesota 55416|
|CCOP - Duluth||Duluth, Minnesota 55805|
|CCOP - Scottsdale Oncology Program||Scottsdale, Arizona 85259-5404|
|CCOP - Cedar Rapids Oncology Project||Cedar Rapids, Iowa 52403-1206|
|Siouxland Hematology-Oncology||Sioux City, Iowa 51101-1733|
|CCOP - Merit Care Hospital||Fargo, North Dakota 58122|
|Altru Health Systems||Grand Forks, North Dakota 58201|
|Rapid City Regional Hospital||Rapid City, South Dakota 57709|
|CCOP - Sioux Community Cancer Consortium||Sioux Falls, South Dakota 57105-1080|
|CCOP - Geisinger Clinic and Medical Center||Danville, Pennsylvania 17822-2001|
|Allegheny General Hospital||Pittsburgh, Pennsylvania 15212-4772|
|CCOP - Toledo Community Hospital||Toledo, Ohio 43623-3456|
|Mayo Clinic||Jacksonville, Florida 32224|
|Medcenter One Health System||Bismarck, North Dakota 58501|
|CentraCare Health Plaza||Saint Cloud, Minnesota 56303|