Docetaxel in Treating Patients With Persistent or Recurrent Cervical Cancer

PRIMARY OBJECTIVES:

I. Determine the antitumor activity of docetaxel in patients with persistent or recurrent squamous cell carcinoma of the cervix.

II. Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour on day 1. 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.

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