A Phase II Evaluation Of Capecitabine (NSC #712807) In The Treatment Of Persistent Or Recurrent Non-Squamous Cell Carcinoma Of The Cervix

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed primary non-squamous cell carcinoma (non-SCC) of the cervix

- Persistent or recurrent disease

- Eligible subtypes include:

- Adenocarcinoma

- Adenosquamous cell carcinoma

- Undifferentiated carcinoma

- Documented disease progression

- At least 1 unidimensionally measurable target lesion outside prior irradiation field

- At least 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT
scan, and MRI) OR

- At least 10 mm by spiral CT scan

- Received 1 prior systemic chemotherapy regimen for advanced, metastatic, or recurrent
non-SCC of the cervix

- Radiosensitizing chemotherapy administered in combination with primary
radiotherapy is not counted as a systemic chemotherapy regimen

- Tissue blocks from initial diagnosis, metastasis, or recurrence available for
submission to the GOG tissue bank

- Ineligible for higher priority Gynecologic Oncology Group (GOG) protocol (if one
exists), defined as any Temporarily closed GOG phase III protocol for the same
patient population

PATIENT CHARACTERISTICS:

Age:

- Not specified

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 Temporarily closed infection requiring antibiotics

- No grade 2 or greater sensory or 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 biological or immunological anticancer agents

- No more than 1 prior non-cytotoxic biologic therapy or cytostatic regimen (e.g.,
monoclonal antibodies, cytokines, or small-molecule inhibitors of signal
transduction) for recurrent or persistent non-SCC of the cervix

Chemotherapy:

- See Disease Characteristics

- See Biologic therapy

- At least 3 weeks since prior chemotherapy and recovered

- No prior capecitabine

- No more than 1 prior cytotoxic chemotherapy regimen (either with single or
combination cytotoxic drug therapy)

Endocrine therapy:

- At least 1 week since prior hormonal anticancer therapy

- Concurrent hormone replacement therapy allowed

Radiotherapy:

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered

Surgery:

- Recovered from prior recent surgery

Other:

- At least 3 weeks since other prior anticancer therapy

- No prior cancer treatment that would preclude this study therapy