Docetaxel in Treating Patients With Persistent or Recurrent Cervical Cancer

Inclusion Criteria:

• Histologically confirmed persistent or recurrent squamous cell carcinoma of the cervix

• Progressive disease

• At least 1 unidimensionally measurable target lesion

• At least 20 mm by conventional techniques

• At least 10 mm by spiral CT scan

• Tumors within a previously irradiated field are not considered target lesions

• One prior systemic chemotherapeutic regimen for advanced, metastatic, or recurrent squamous cell carcinoma of the cervix required

• Chemotherapy administered as a radiosensitizer in conjunction with primary radiotherapy is not considered a systemic chemotherapy regimen

• Ineligible for a higher priority GOG protocol (e.g., any active Phase III GOG protocol or GOG-0076)

• Performance status - GOG 0-2

• Absolute neutrophil count at least 1,500/mm3

• Platelet count at least 100,000/mm3

• 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 no greater than 1.5 times ULN

• No congestive heart failure

• No unstable angina, myocardial infarction, or new cardiac arrhythmia within the past 6 months

• Negative pregnancy test

• Fertile patients must use effective contraception

• No active infection requiring antibiotics

• No greater than grade 1 sensory and motor neuropathy

• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

• At least 3 weeks since prior biologic or immunologic therapy directed at malignant tumor

• One prior noncytotoxic regimen (e.g., monoclonal antibodies, cytokines, or small-molecule signal transduction inhibitors) for recurrent or persistent disease allowed

• Recovered from prior chemotherapy

• No prior docetaxel

• No more than 1 prior cytotoxic chemotherapy regimen

• At least one week since prior hormonal therapy directed at malignant tumor

• Concurrent hormone replacement therapy allowed

• Recovered from prior radiotherapy

• Recovered from recent prior surgery

• At least 3 weeks since any prior therapy directed at malignant tumor

• No prior anticancer therapy that would preclude study

• No concurrent amifostine or other protective agents