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
OBJECTIVES:
- 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.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Alex A. Adjei, MD, PhD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000068838
NCT00022646
August 2001
Name | Location |
---|---|
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 |