Capecitabine in Treating Patients With Persistent or Recurrent Cervical Cancer

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