A Phase II Evaluation Of Docetaxel (NSC #628503) In The Treatment Of Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix

Inclusion Criteria

DISEASE CHARACTERISTICS:

- 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 OR

- 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)

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- GOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm3

- Platelet count at least 100,000/mm3

Hepatic:

- 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

Renal:

- Creatinine no greater than 1.5 times ULN

Cardiovascular:

- No congestive heart failure

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

Other:

- 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- 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

Chemotherapy:

- See Disease Characteristics

- Recovered from prior chemotherapy

- No prior docetaxel

- No more than 1 prior cytotoxic chemotherapy regimen

Endocrine therapy:

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

- Concurrent hormone replacement therapy allowed

Radiotherapy:

- See Disease Characteristics

- Recovered from prior radiotherapy

Surgery:

- Recovered from recent prior surgery

Other:

- 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