Clinical Trial: Capecitabine in Treating Patients With Persistent or Recurrent Cervical Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Gynecologic Oncology Group

Current Primary Outcome:

  • Duration of objective response [ Time Frame: Up to 7 years ]
  • Frequency of adverse events, graded according to CTC version 2.0 [ Time Frame: Up to 7 years ]
  • Frequency of objective response [ Time Frame: Up to 7 years ]
  • Severity of observed adverse events, graded according CTC version 2.0 [ Time Frame: Up to 7 years ]


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Gynecologic Oncology Group

Dates:
Date Received: June 6, 2002
Date Started: April 2002
Date Completion:
Last Updated: December 7, 2016
Last Verified: December 2016