Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
- 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
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
Holden Comprehensive Cancer Center
🇺🇸Iowa City, Iowa, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
🇺🇸Bethesda, Maryland, United States
Norwegian Radium Hospital
🇳🇴Oslo, Norway
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Keesler Medical Center - Keesler AFB
🇺🇸Keesler AFB, Mississippi, United States
Brookview Research, Inc.
🇺🇸Nashville, Tennessee, United States