Capecitabine in Treating Patients With Persistent or Recurrent Cervical Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Recurrent Cervical Carcinoma

Intervention / Treatment
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* Drug: Capecitabine
* Other: Laboratory Biomarker Analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed primary non-squamous cell carcinoma (non-SCC) of the cervix Persistent or recurrent disease Eligible subtypes include: Adenocarcinoma Adenosquamous cell carcinoma Undifferentiated carcinoma Documented disease progression At least 1 unidimensionally measurable target lesion outside prior irradiation field At least 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, and MRI) At least 10 mm by spiral CT scan Received 1 prior systemic chemotherapy regimen for advanced, metastatic, or recurrent non-SCC of the cervix Radiosensitizing chemotherapy administered in combination with primary radiotherapy is not counted as a systemic chemotherapy regimen Tissue blocks from initial diagnosis, metastasis, or recurrence available for submission to the GOG tissue bank Ineligible for higher priority Gynecologic Oncology Group (GOG) protocol (if one exists), defined as any Temporarily closed GOG phase III protocol for the same patient population Performance status - GOG 0-2 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Creatinine clearance at least 50 mL/min Not pregnant Negative pregnancy test Fertile patients must use effective contraception No Temporarily closed infection requiring antibiotics No grade 2 or greater sensory or motor neuropathy No other invasive malignancy within the past 5 years except nonmelanoma skin cancer At least 3 weeks since prior biological or immunological anticancer agents No more than 1 prior non-cytotoxic biologic therapy or cytostatic regimen (e.g., monoclonal antibodies, cytokines, or small-molecule inhibitors of signal transduction) for recurrent or persistent non-SCC of the cervix See Disease Characteristics See Biologic therapy At least 3 weeks since prior chemotherapy and recovered No prior capecitabine No more than 1 prior cytotoxic chemotherapy regimen (either with single or combination cytotoxic drug therapy) At least 1 week since prior hormonal anticancer therapy Concurrent hormone replacement therapy allowed See Disease Characteristics At least 3 weeks since prior radiotherapy and recovered Recovered from prior recent surgery At least 3 weeks since other prior anticancer therapy No prior cancer treatment that would preclude this study therapy
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Patients receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. | Drug: Capecitabine<br>* Given orally<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of objective response |  | Up to 7 years | 
| Frequency of adverse events, graded according to CTC version 2.0 |  | Up to 7 years | 
| Frequency of objective response |  | Up to 7 years | 
| Severity of observed adverse events, graded according CTC version 2.0 |  | Up to 7 years |