Capecitabine in Treating Patients With Persistent or Recurrent Cervical Cancer
Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Recurrent Cervical Carcinoma
About this trial
This is an interventional treatment trial for Cervical Adenocarcinoma
Eligibility Criteria
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
Sites / Locations
- Gynecologic Oncology Group of Arizona
Arms of the Study
Arm 1
Experimental
Treatment
Patients receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.