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Topotecan and Paclitaxel in Treating Patients With Recurrent or Metastatic Cancer of the Cervix

Phase 2
Completed
Conditions
Cervical Cancer
Registration Number
NCT00003065
Lead Sponsor
Herbert Irving Comprehensive Cancer Center
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 II trial to study the effectiveness of topotecan and paclitaxel in treating patients who have recurrent or metastatic cancer of the cervix.

Detailed Description

OBJECTIVES:

* Determine the response, time to progression, disease free survival, and overall survival of patients with recurrent and/or metastatic cancer of the cervix treated with a combination of topotecan and paclitaxel.

* Determine the feasibility and toxicity of this regimen in these patients.

OUTLINE: Patients receive paclitaxel IV over 3 hours on day 1 and topotecan IV over 30 minutes on days 1-5. Filgrastim (G-CSF) is administered on days 6-14. Treatment repeats every 21 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 weeks.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2 years.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
25
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Herbert Irving Comprehensive Cancer Center at Columbia University

πŸ‡ΊπŸ‡Έ

New York, New York, United States

Herbert Irving Comprehensive Cancer Center at Columbia University
πŸ‡ΊπŸ‡ΈNew York, New York, United States

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