NCT00004081

Docetaxel in Treating Women With Ovarian Epithelial or Primary Peritoneal Cancer

A Phase II Trial of Weekly, Low-Dose Docetaxel (Taxotere) in Patients With Platinum-Resistant Epithelial Ovarian or Primary Peritoneal Serous Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: Female
• 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. PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating women who have ovarian epithelial cancer or primary peritoneal cancer that has not responded to previous treatment.

Detailed description

OBJECTIVES: * Determine the activity of docetaxel in women with platinum resistant, refractory ovarian epithelial or primary peritoneal serous cancer. OUTLINE: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive a minimum of 6 courses of therapy, including 2 courses beyond CR. PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 2 years.

Conditions

• Ovarian Cancer
• Peritoneal Cavity Cancer

Interventions

Type	Name	Description
DRUG	docetaxel

Timeline

• Start date: 1999-07-01
• Primary completion: 2002-01-01
• Completion: 2003-03-01
• First posted: 2003-01-27
• Last updated: 2012-08-13

Locations

1 site across 1 country: United States