A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With Metastatic Breast Cancer
OBJECTIVES:
- 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
regimen.
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
courses.
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.
Interventional
Primary Purpose: Treatment
Alex A. Adjei, MD, PhD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000068015
NCT00006007
December 2000
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 - 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 |