Clinical Trials Directory

Trials / Completed

CompletedNCT00039442

Capecitabine in Treating Patients With Persistent or Recurrent Cervical Cancer

A Phase II Evaluation Of Capecitabine (NSC #712807) In The Treatment Of Persistent Or Recurrent Non-Squamous Cell Carcinoma Of The Cervix

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
21 (actual)
Sponsor
Gynecologic Oncology Group · Network
Sex
Female
Age
—
Healthy volunteers
Not accepted

Summary

Phase II trial to study the effectiveness of capecitabine in treating patients who have persistent or recurrent cervical cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Detailed description

PRIMARY OBJECTIVES: I. 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. II. Determine the nature and degree of toxicity of this drug in these patients. III. 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. IV. Determine whether the serum level of TP is a potential prognostic indicator of clinical outcomes (response and survival) in patients treated with this drug. V. 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. VI. 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.

Conditions

Interventions

TypeNameDescription
DRUGCapecitabineGiven orally
OTHERLaboratory Biomarker AnalysisCorrelative studies

Timeline

Start date
2002-04-29
Primary completion
2005-12-07
First posted
2003-01-27
Last updated
2017-08-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00039442. Inclusion in this directory is not an endorsement.