Pemetrexed Disodium Plus Gemcitabine in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug and giving the drugs in different ways may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of three different regimens of pemetrexed disodium plus gemcitabine in treating patients who have locally advanced or metastatic non-small cell lung cancer.
Drug: gemcitabine hydrochloride
Drug: pemetrexed disodium
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
|Study Start Date:||August 2001|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
- 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 and gemcitabine.
- 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 patients.
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.
|United States, Arizona|
|CCOP - Scottsdale Oncology Program|
|Scottsdale, Arizona, United States, 85259-5404|
|United States, Florida|
|Jacksonville, Florida, United States, 32224|
|United States, Illinois|
|CCOP - Illinois Oncology Research Association|
|Peoria, Illinois, United States, 61602|
|CCOP - Carle Cancer Center|
|Urbana, Illinois, United States, 61801|
|United States, Iowa|
|CCOP - Cedar Rapids Oncology Project|
|Cedar Rapids, Iowa, United States, 52403-1206|
|CCOP - Iowa Oncology Research Association|
|Des Moines, Iowa, United States, 50309-1016|
|Sioux City, Iowa, United States, 51101-1733|
|United States, Kansas|
|CCOP - Wichita|
|Wichita, Kansas, United States, 67214-3882|
|United States, Michigan|
|CCOP - Ann Arbor Regional|
|Ann Arbor, Michigan, United States, 48106|
|United States, Minnesota|
|CCOP - Duluth|
|Duluth, Minnesota, United States, 55805|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|CentraCare Health Plaza|
|Saint Cloud, Minnesota, United States, 56303|
|CCOP - Metro-Minnesota|
|Saint Louis Park, Minnesota, United States, 55416|
|United States, Nebraska|
|CCOP - Missouri Valley Cancer Consortium|
|Omaha, Nebraska, United States, 68106|
|United States, North Dakota|
|Medcenter One Health System|
|Bismarck, North Dakota, United States, 58501|
|CCOP - Merit Care Hospital|
|Fargo, North Dakota, United States, 58122|
|Altru Health Systems|
|Grand Forks, North Dakota, United States, 58201|
|United States, Ohio|
|CCOP - Toledo Community Hospital|
|Toledo, Ohio, United States, 43623-3456|
|United States, Pennsylvania|
|CCOP - Geisinger Clinic and Medical Center|
|Danville, Pennsylvania, United States, 17822-2001|
|Allegheny General Hospital|
|Pittsburgh, Pennsylvania, United States, 15212-4772|
|United States, South Dakota|
|Rapid City Regional Hospital|
|Rapid City, South Dakota, United States, 57709|
|CCOP - Sioux Community Cancer Consortium|
|Sioux Falls, South Dakota, United States, 57104|
|Study Chair:||Alex A. Adjei, MD, PhD||Mayo Clinic|