Spots Global Cancer Trial Database for Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
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Trial Identification
Brief Title: Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
Official Title: A Limited Access Phase II Trial Of Capecitabine In Advanced, Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix
Study ID: NCT00016926
Conditions
Interventions
Study Description
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.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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
Contact Details
Name: Agustin Garcia, MD
Affiliation: University of Southern California
Role: STUDY_CHAIR
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