A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With Metastatic Breast Cancer
- Assess the antitumor activity of pemetrexed disodium in combination with gemcitabine in
the treatment of women with metastatic breast cancer who have received an anthracycline
and a taxane in the adjuvant and/or metastatic setting and no more than 1 chemotherapy
regimen for metastatic disease (unless these were a taxane and anthracycline).
- Determine the toxicity of this regimen in this patient population.
- Determine time to progression and overall survival of these patients receiving this
OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1 and 8. pemetrexed
disodium IV is administered over 10 minutes 90 minutes following gemcitabine on day 8.
Treatment continues every 21 days for a minimum of 6 courses in the absence of unacceptable
toxicity or disease progression. Patients achieving a complete response receive 2 additional
Patients are followed every 3 months for 5 years.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 1 year.
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 - Ochsner||New Orleans, Louisiana 70121|
|CCOP - Merit Care Hospital||Fargo, North Dakota 58122|
|Altru Health Systems||Grand Forks, North Dakota 58201|
|CCOP - Toledo Community Hospital Oncology Program||Toledo, Ohio 43623-3456|
|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|
|Mayo Clinic||Jacksonville, Florida 32224|
|Medcenter One Health System||Bismarck, North Dakota 58501|
|CentraCare Health Plaza||Saint Cloud, Minnesota 56303|
|Illinois Oncology Research Association||Peoria, Illinois 61602|