Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Limited Access Phase II Trial Of Capecitabine In Advanced, Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix|
|Study Start Date:||April 2001|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
- 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.
|United States, California|
|Chao Family Comprehensive Cancer Center|
|Orange, California, United States, 92868|
|United States, Indiana|
|Indiana University Cancer Center|
|Indianapolis, Indiana, United States, 46202-5289|
|United States, Iowa|
|Holden Comprehensive Cancer Center|
|Iowa City, Iowa, United States, 52242-1009|
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|United States, Mississippi|
|University of Mississippi Medical Center|
|Jackson, Mississippi, United States, 39216-4505|
|Keesler Medical Center - Keesler AFB|
|Keesler AFB, Mississippi, United States, 39534-2576|
|United States, North Carolina|
|Comprehensive Cancer Center at Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157-1065|
|United States, Tennessee|
|Brookview Research, Inc.|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|University of Texas Medical Branch|
|Galveston, Texas, United States, 77555-0587|
|Norwegian Radium Hospital|
|Oslo, Norway, N-0310|
|Study Chair:||Agustin Garcia, MD||University of Southern California|