Docetaxel in Treating Patients With Persistent or Recurrent Cervical Cancer
Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Recurrent Cervical Carcinoma
About this trial
This is an interventional treatment trial for Cervical Squamous Cell Carcinoma, Not Otherwise Specified
Eligibility Criteria
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
Sites / Locations
- Gynecologic Oncology Group
Arms of the Study
Arm 1
Experimental
Treatment (docetaxel)
Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.