MedPath

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

🇺🇸

New York, New York, United States

© Copyright 2025. All Rights Reserved by MedPath