Paclitaxel, Topotecan, and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer

Phase 2

Completed

• Conditions: Cervical Cancer

• Registration Number: NCT00276796
• Lead Sponsor: Gynecologic Oncology Group

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, topotecan, and cisplatin, 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 paclitaxel together with topotecan and cisplatin works in treating patients with advanced, persistent, or recurrent cervical cancer.

Detailed Description

OBJECTIVES:

Primary

* Estimate the antitumor activity of the combination of paclitaxel, topotecan, and cisplatin in patients with advanced, persistent, or recurrent carcinoma of the cervix.

* Determine the nature and degree of toxicity for this drug regimen in these patients.

Secondary

* Determine the duration of progression-free survival and overall survival.

* Determine the impact of prior chemoradiation on response to treatment.

OUTLINE: This is an open-label study.

Patients receive paclitaxel IV over 1 hour followed by topotecan IV over 30 minutes and cisplatin IV over 1 hour on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 66 patients will be accrued for this study.

Study Timeline

• Study First Submitted: 2006-01-12
• Study First Submitted QC: 2006-01-12
• Study First Posted: 2006-01-13
• Primary Completion: 2007-01
• Status Verified: 2009-02
• Last Update Submitted: 2013-05-24
• Last Update Posted: 2013-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The frequency and duration of objective response
The frequency and severity of observed adverse effects

Secondary Outcome Measures

Name	Time	Method
Progression-free survival and overall survival
Prognostic factor: prior chemoradiation