Capecitabine in Treating Patients With 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 persistent or recurrent cervical cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Evaluation Of Capecitabine (NSC #712807) In The Treatment Of Persistent Or Recurrent Non-Squamous Cell Carcinoma Of The Cervix|
|Study Start Date:||June 2002|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
- Determine the antitumor activity of capecitabine in patients with persistent or recurrent non-squamous cell carcinoma of the cervix who have failed higher priority treatment protocols.
- Determine the nature and degree of toxicity of this drug in these patients.
- Determine whether the mRNA tumor expression levels of thymidylate synthase (TS), dihydropyrimidine dehydrogenase (DPD), and thymidine phosphorylase (TP) at baseline are potential predictors of clinical outcomes (response and survival) in patients treated with this drug.
- Determine whether the serum level of TP is a potential prognostic indicator of clinical outcomes (response and survival) in patients treated with this drug.
- Determine whether the TS promoter polymorphism in peripheral blood is a potential prognostic indicator of clinical outcomes (response and survival) in patients treated with this drug.
- Determine the associations among the various measures of TS, DPD, and TP and clinical outcomes (response and survival) in patients treated with this drug.
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 15-37 patients will be accrued for this study within approximately 5-12 months.
Show 48 Study Locations
|Study Chair:||Katherine Y. Look, MD||Indiana University Melvin and Bren Simon Cancer Center|
|Investigator:||Agustin Garcia, MD||Cedars-Sinai Medical Center|