Phase II Trial of Docetaxel and Carboplatin as First-Line Therapy for Metastatic Breast Cancer
OBJECTIVES: I. Determine the anti-tumor activity of docetaxel and carboplatin in women with
metastatic adenocarcinoma of the breast. II. Determine the objective response rate, time to
progression, and survival in patients treated with this regimen. III. Determine the toxic
effects of this regimen in these patients. IV. Assess the common functional polymorphisms in
genes involved in chemotherapeutic response to improve prediction of clinical outcomes and
provide insight into the potential for genotype-specific drug dosage.
OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour and
carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks in the absence of
disease progression or unacceptable toxicity. Patients who achieve stable disease (SD),
partial response (PR), or complete response (CR) may receive 4 additional courses past SD,
PR, or CR. Patients are followed every 6 months for 2 years and then annually for 3 years.
PROJECTED ACCRUAL: A maximum of 55 patients will be accrued for this study within 11 months.
Interventional
Primary Purpose: Treatment
Edith A. Perez, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000067945
NCT00005963
November 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 |
CentraCare Clinic | Saint Cloud, Minnesota 56303 |
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 |
Medcenter One Health System | Bismarck, North Dakota 58501 |