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Paclitaxel in Treating Patients With Advanced, Refractory, or Recurrent Cervical or Vaginal Cancer

Phase 2
Completed
Conditions
Cervical Cancer
Vaginal Cancer
Registration Number
NCT00002562
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.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with advanced, refractory, or recurrent cervical or vaginal cancer.

Detailed Description

OBJECTIVES: I. Estimate the frequency and duration of objective response, duration of progression-free interval, and survival of patients treated with paclitaxel for advanced, persistent, or recurrent clear cell adenocarcinoma of the vagina and cervix who have failed higher priority treatment protocols. II. Determine the frequency and severity of observed adverse effects on this study.

OUTLINE: Single-Agent Chemotherapy. Paclitaxel, TAX, NSC-673089.

PROJECTED ACCRUAL: 25 evaluable patients per histologic stratum will be accrued over 10-12 months for the nonsquamous cell carcinoma stratum and over 23 months for the clear cell adenocarcinoma stratum. If more than 3 patients in a given stratum respond, an additional 25 patients will be accrued to that stratum. As of 07/95, the study is open only to patients with clear cell adenocarcinoma of the vagina or cervix.

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 (50)

University of Alabama Comprehensive Cancer Center

🇺🇸

Birmingham, Alabama, United States

USC/Norris Comprehensive Cancer Center

🇺🇸

Los Angeles, California, United States

Jonsson Comprehensive Cancer Center, UCLA

🇺🇸

Los Angeles, California, United States

Women's Cancer Center

🇺🇸

Palo Alto, California, United States

Stanford University Medical Center

🇺🇸

Stanford, California, United States

University of Colorado Cancer Center

🇺🇸

Denver, Colorado, United States

Vincent T. Lombardi Cancer Research Center, Georgetown University

🇺🇸

Washington, District of Columbia, United States

Walter Reed Army Medical Center

🇺🇸

Washington, District of Columbia, United States

H. Lee Moffitt Cancer Center and Research Institute

🇺🇸

Tampa, Florida, United States

Emory University Hospital - Atlanta

🇺🇸

Atlanta, Georgia, United States

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University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States

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