Liposomal Doxorubicin and Carboplatin in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Phase 1

Completed

• Conditions: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

• Registration Number: NCT00006235
• Lead Sponsor: Gynecologic Oncology Group

Brief 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 liposomal doxorubicin and carboplatin in treating patients who have recurrent ovarian, fallopian tube, or primary peritoneal cancer.

Detailed Description

OBJECTIVES: I. Determine the maximum tolerated dose of doxorubicin HCl liposome (Doxil) when combined with carboplatin in patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer. II. Determine the toxicity of this regimen in these patients. III. Determine the rate of response in patients treated with this regimen.

OUTLINE: This is a dose escalation, multicenter study of doxorubicin HCl liposome (Doxil). Patients receive Doxil IV over 1 hour and carboplatin IV on day 1. Treatment continues every 4 weeks for a minimum of 6 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of Doxil until the maximum tolerated dose (MTD) is determined. The MTD is defined as the highest dose at which 0 or 1 of 6 patients experience dose limiting toxicity. Patients are followed every 3 months for 2 years, then every 6 months for 3 years, and then annually thereafter until recurrence or death.

PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study over 1 year.

Study Timeline

• Study First Submitted: 2000-09-11
• Study First Submitted QC: 2004-06-21
• Study First Posted: 2004-06-22
• Status Verified: 2006-02
• Primary Completion: 2006-02
• Last Update Submitted: 2013-07-08
• Last Update Posted: 2013-07-09

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