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A Phase I Study of Docetaxel (Taxotere), Carboplatin, and Gemcitabine (DoCaGem) as First-Line Therapy for Patients With High-Risk Epithelial Tumors of Mullerian Origin
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining docetaxel, carboplatin, and gemcitabine in treating patients who have previously untreated, newly diagnosed epithelial cancer.
OBJECTIVES: I. Determine the maximum tolerated dose of docetaxel, carboplatin, and gemcitabine in patients with previously untreated, newly diagnosed, high-risk epithelial cancer of mullerian origin. OUTLINE: This is a dose-escalation study of docetaxel and gemcitabine. Patients receive docetaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1 and 8. Carboplatin IV is administered over 30 minutes on day 1. Treatment repeats every 21-28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-5 patients receive escalating doses of docetaxel and gemcitabine until the maximum tolerated dose is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 5 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 1.5-2 years.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Start Date
July 1, 1999
Primary Completion Date
September 1, 2003
Completion Date
December 1, 2010
Last Updated
June 26, 2013
carboplatin
DRUG
docetaxel
DRUG
gemcitabine hydrochloride
DRUG
Lead Sponsor
Beth Israel Deaconess Medical Center
NCT05039801
NCT04550494
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