A Limited Access Phase II Trial Of Capecitabine In Advanced, Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed advanced, persistent, or recurrent squamous cell carcinoma
of the cervix

- Documented disease progression after local therapy and considered incurable

- At least 1 target lesion measurable in at least 1 dimension

- At least 20 mm by conventional techniques, including palpation, plain x-ray, CT
scan, or MRI OR at least 10 mm by spiral CT scan

- Target lesion cannot be in a previously irradiated field

PATIENT CHARACTERISTICS:

Age:

- Any age

Performance status:

- GOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

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 clearance at least 50 mL/min

Other:

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active infection requiring antibiotics

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

- No neuropathy (sensory and motor) greater than grade I

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 3 weeks since prior biologic therapy or immunotherapy for the malignant
tumor

- No concurrent prophylactic filgrastim (G-CSF)

Chemotherapy:

- At least 3 weeks since prior chemotherapy for the malignant tumor and recovered

- No prior cytotoxic therapy (except when used as a radiosensitizer)

- No prior chemotherapy for other malignancy

Endocrine therapy:

- At least 1 week since prior hormonal therapy for the malignant tumor

- Concurrent hormone replacement therapy allowed

Radiotherapy:

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy for the malignant tumor and recovered

- No prior radiotherapy for other malignancy

Surgery:

- Recovered from prior surgery

Other:

- At least 3 weeks since any other prior therapy for the malignant tumor

- No prior anticancer therapy that contraindicates study therapy

- No concurrent amifostine or other protective reagents