Cervical Adenocarcinoma Clinical Trial
Official title:
A Phase II Evaluation Of Capecitabine (NSC #712807) In The Treatment Of Persistent Or Recurrent Non-Squamous Cell Carcinoma Of The Cervix
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.
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.
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