A Limited Access Phase II Trial of Pemetrexed (Alimta, LY231514) (NSC #698037) in Combination With Cisplatin (NSC #119875) in the Treatment of Advanced, Persistent, or Recurrent Carcinoma of the Cervix

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed squamous or nonsquamous cell carcinoma of the cervix

- Advanced, persistent, or recurrent disease

- Disease not amenable to curative therapy

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques or ≥ 10 mm by spiral CT scan

- Must have ≥ 1 target lesion to be used to assess response

- Tumors within a previously irradiated field will be designated as "non-target"
lesions unless progression is documented or a biopsy is obtained to confirm
persistence ≥ 90 days following completion of radiotherapy

PATIENT CHARACTERISTICS:

- GOG performance status 0-2

- Platelet count ≥ 100,000/mm^3

- ANC ≥ 1,500/mm^3

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- Creatinine clearance ≥ 60 mL/min

- SGOT ≤ 2.5 times ULN (≤ 5 times ULN if due to hepatic metastases)

- Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN if due to hepatic metastases)

- Negative pregnancy test

- Fertile patients must use effective contraception

- Neuropathy (sensory and motor) ≤ grade 1

- Able to take folic acid, vitamin B12, and dexamethasone according to study protocol

- No history of other invasive malignancies within the past 5 years, except nonmelanoma
skin cancer

- No active infection requiring antibiotics

- No presence of third space fluid which cannot be controlled by drainage

PRIOR CONCURRENT THERAPY:

- Recovered from effects of recent surgery, radiotherapy, or other therapy

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

- At least 4 weeks since prior radiotherapy

- More than 3 years since prior radiotherapy for localized cancer of the breast, head
and neck, or skin and patient remains free of recurrent or metastatic disease

- No prior radiotherapy to any portion of the abdominal cavity or pelvis except for the
treatment of cervical cancer

- No prior radiotherapy to more than 25% of marrow-bearing areas

- No prior cancer treatment that contraindicates study treatment

- No prior cytotoxic drugs for advanced or recurrent carcinoma of the cervix

- Prior cisplatin as a radiosensitizer for primary treatment of disease allowed

- No nonsteroidal anti-inflammatory drugs (NSAIDs) or salicylates 2-5 days before,
during, or for 2 days after receiving pemetrexed disodium

- No NSAIDS with a long half-life (e.g., naproxen, piroxicam, diflunisal, or
nabumetone) 5 days before, during, and for 2 days after receiving pemetrexed
disodium

- Concurrent hormone replacement therapy is permitted

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

- Concurrent use of acetylsalicylic acid (up to 1.3 g/day) allowed