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Phase II Trial of Docetaxel and Carboplatin as First-Line Therapy for Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and carboplatin in treating women who have 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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
Siouxland Hematology-Oncology
Sioux City, Iowa, United States
CCOP - Wichita
Wichita, Kansas, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States
CCOP - Duluth
Duluth, Minnesota, United States
Start Date
November 1, 2000
Primary Completion Date
October 1, 2002
Completion Date
January 1, 2009
Last Updated
December 7, 2016
53
ACTUAL participants
carboplatin
DRUG
docetaxel
DRUG
Lead Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
NCT05245812
NCT05673200
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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