Gemcitabine and Carboplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer That Responded to Previous Cisplatin or Carboplatin

Phase 2

Withdrawn

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

• Registration Number: NCT00369954
• Lead Sponsor: Gynecologic Oncology Group

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine 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) and giving them in different ways may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving gemcitabine together with carboplatin works in treating patients with persistent or recurrent ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer that responded to previous cisplatin or carboplatin.

Detailed Description

OBJECTIVES:

Primary

* Determine the progression-free survival of patients with persistent or recurrent platinum-sensitive ovarian epithelial, fallopian tube, or primary peritoneal cancer treated with gemcitabine hydrochloride and intraperitoneal carboplatin.

* Evaluate the systemic and regional toxicity of this regimen in these patients.

Secondary

* Determine the overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine hydrochloride IV over 30 minutes followed by intraperitoneal carboplatin on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 3 years.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-08-29
• Study First Submitted QC: 2006-08-29
• Study First Posted: 2006-08-30
• Status Verified: 2007-10
• Last Update Submitted: 2013-06-07
• Last Update Posted: 2013-06-10

Recruitment & Eligibility

• Status: WITHDRAWN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

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relative risk of progression-free survival
Frequency and severity of observed adverse effects by CTCAE version 3.0

Secondary Outcome Measures

Name	Time	Method
Relative risk of survival