Capecitabine in Treating Patients With Persistent or Recurrent Cervical Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Capecitabine

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