Phase II Study of Gemcitabine (GEMZAR) and Cisplatin (CDDP) in Advanced Breast Cancer
OBJECTIVES: I. Assess the response rate of gemcitabine and cisplatin in the treatment of
metastatic breast cancer in patients who have failed one or two systemic regimens. II.
Determine time to progression and survival in these patients. III. Define further the
toxicity of this two-drug combination in these patients.
OUTLINE: This is a nonrandomized study. Patients receive gemcitabine IV over 30 minutes and
cisplatin IV over 1 hour on days 1, 8, and 15 every 28 days. Patients with complete response
may receive an additional 2 courses after attainment of complete response status. Treatment
continues in the absence of disease progression or unacceptable toxicities for a maximum of
8 courses. Patients are followed every 3 months for 2 years and then at 3 years after
treatment.
PROJECTED ACCRUAL: A maximum of 50 patients will be accrued into this study in approximately
9 months.
Interventional
Primary Purpose: Treatment
Patrick A. Burch, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000065548
NCT00002998
August 1997
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 - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
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 |
CentraCare Clinic | Saint Cloud, Minnesota 56303 |
Quain & Ramstad Clinic, P.C. | Bismarck, North Dakota 58501 |
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 |
CCOP - Geisinger Clinical and Medical Center | Danville, Pennsylvania 17822-2001 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |