Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00016926|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 27, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Drug: capecitabine||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|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|
|Actual Primary Completion Date :||July 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00016926
|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|