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Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer

Phase 2
Completed
Conditions
Cervical Cancer
Registration Number
NCT00016926
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 capecitabine in treating patients who have advanced, persistent, or recurrent cervical cancer.

Detailed Description

OBJECTIVES:

* Determine the activity of capecitabine in patients with advanced, persistent, or recurrent squamous cell carcinoma of the cervix.

* Determine the toxicity profile of this drug in this patient population.

OUTLINE: This is a multicenter study.

Patients receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 28-62 patients will be accrued for this study within 9-20 months.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
Not specified
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 (10)

Chao Family Comprehensive Cancer Center

🇺🇸

Orange, California, United States

Indiana University Cancer Center

🇺🇸

Indianapolis, Indiana, United States

Holden Comprehensive Cancer Center

🇺🇸

Iowa City, Iowa, United States

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

🇺🇸

Bethesda, Maryland, United States

University of Mississippi Medical Center

🇺🇸

Jackson, Mississippi, United States

Keesler Medical Center - Keesler AFB

🇺🇸

Keesler AFB, Mississippi, United States

Comprehensive Cancer Center at Wake Forest University

🇺🇸

Winston-Salem, North Carolina, United States

Brookview Research, Inc.

🇺🇸

Nashville, Tennessee, United States

University of Texas Medical Branch

🇺🇸

Galveston, Texas, United States

Norwegian Radium Hospital

🇳🇴

Oslo, Norway

Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States

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