Docetaxel and Carboplatin in Treating Patients With Relapsed Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cavity Cancer

Phase 2

Completed

• Conditions: Ovarian Cancer; Peritoneal Cavity Cancer

• Registration Number: NCT00217568
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel together with carboplatin works in treating patients with relapsed stage III or stage IV ovarian epithelial or primary peritoneal cavity cancer.

Detailed Description

OBJECTIVES:

* Determine the toxicity of docetaxel and carboplatin in patients with platinum-sensitive stage III or IV ovarian epithelial or primary peritoneal cavity cancer in first relapse.

* Determine the response rates (complete and partial response) in patients treated with this regimen.

* Determine relapse rates and event-free survival and overall survival rates in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Patients also receive pegfilgrastim subcutaneously on day 2 . Treatment repeats every 21 days for up to 6 courses.

After completion of study treatment, patients are followed at 3 weeks, every 3 months for 2 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4-5 years.

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-09-20
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-22
• Primary Completion: 2006-03
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-20
• Last Update Posted: 2010-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Toxicity
Response rates (complete and partial response)
Relapse rates
Event-free survival
Overall survival

Trial Locations

Locations (3)

University of Washington School of Medicine; 🇺🇸 Seattle, Washington, United States

Pacific Gynecology Specialists; 🇺🇸 Seattle, Washington, United States

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States