NCT00004082

Combination Chemotherapy in Treating Patients With Previously Untreated, Newly Diagnosed Epithelial Tumors

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Endometrial Cancer
• Fallopian Tube Cancer
• Ovarian Cancer
• Primary Peritoneal Cavity Cancer

Interventions

Type	Name	Description
DRUG	carboplatin
DRUG	docetaxel
DRUG	gemcitabine hydrochloride

Timeline

• Start date: 1999-07-01
• Primary completion: 2003-09-01
• Completion: 2010-12-01
• First posted: 2004-04-12
• Last updated: 2013-06-26

Locations

1 site across 1 country: United States