A Phase II Evaluation Of Pemetrexed (ALIMTA, LY231517, IND #40061) In the Treatment Of Recurrent Carcinoma Of The Cervix

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed carcinoma of the cervix

- Squamous cell or non-squamous cell

- Recurrent disease

- Progressive disease

- Measurable disease

- At least 1 unidimensionally measurable target lesion ≥ 20 mm by conventional
techniques, including palpation, plain x-ray, CT scan, or MRI OR ≥ 10 mm by
spiral CT scan

- Tumors within a previously irradiated field are considered non-target lesions
unless disease progression is documented or a biopsy is obtained to confirm
persistence at least 90 days after completion of radiotherapy

- Not amenable to surgery, radiotherapy, or other therapy

- Must have received 1 prior systemic chemotherapy regimen for persistent or recurrent
squamous cell or non-squamous cell carcinoma of the cervix

- Chemotherapy administered with primary radiotherapy as a radiosensitizer is not
considered a systemic chemotherapy regimen

- Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG
protocol for the same patient population)

PATIENT CHARACTERISTICS:

Age

- Any age

Performance status

- GOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 g/dL

Hepatic

- AST and ALT ≤ 3 times upper limit of normal (ULN)*

- Alkaline phosphatase ≤ 3 times ULN*

- Bilirubin ≤ 1.5 times ULN NOTE: * ≤ 5 times ULN if liver metastases are present

Renal

- Creatinine clearance ≥ 45 mL/min

Other

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception during and for at least 3 months
after study participation

- Neuropathy (sensory and motor) ≤ grade 1

- No active infection requiring antibiotics

- 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 agents for the malignant tumor

- At least 24 hours since prior growth factors

- One prior non-cytotoxic (biologic or cytostatic) regimen for recurrent or persistent
disease allowed, including, but not limited to, the following:

- Monoclonal antibodies

- Cytokines

- Small-molecule inhibitors of signal transduction

- No concurrent routine colony-stimulating factors

Chemotherapy

- See Disease Characteristics

- Recovered from prior chemotherapy

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

- No prior pemetrexed disodium

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 2 weeks since prior radiotherapy and recovered

- No prior radiotherapy to > 25% of bone marrow

Surgery

- Recovered from prior surgery

Other

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

- No nonsteroidal anti-inflammatory drugs for 2-5 days before, during, and for 1-2 days
after study drug administration

- Concurrent daily low-dose (≤ 325 mg/day) aspirin therapy allowed

- No prior therapy that would contraindicate study participation