| Inclusion Criteria: | 1) Patients must have advanced, persistent, or recurrent squamous or non-squamous cell carcinoma of the cervix not amenable to curative therapy. Histologic documentation of the original primary tumor is required via the pathology report.
2) All patients must have measurable disease. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be >/= 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or >/= 10 mm when measured by spiral CT.
3) Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST. 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 at least 90 days following completion of radiation therapy.
4) Patients must have a GOG Performance Status of 0, 1, or 2.
5) Recovery from effects of recent surgery, radiotherapy or other therapy. Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated UTI). Any hormonal therapy directed at the malignant tumor must be discontinued at least 1 week prior to registration. Continuation of hormone replacement therapy is permitted. Any prior radiotherapy must be discontinued at least 4 weeks prior to registration.
6) Patients must have adequate: Bone marrow function: Platelet count greater than or equal to 100,000/mcl and ANC count greater than or equal to 1,500/mcl, equivalent to CTCAE v3.0 grade 1. Renal function: CrCl >/= 60 ml/min as measured by Jeliffe. Hepatic function: Bilirubin less than or equal to 1.5 x ULN (CTCAE v3.0 grade 1). SGOT and alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v3.0 grade 1) (if known hepatic metastases SGOT and alkaline phosphatase may be </= 5 x ULN). Neurologic function: Neuropathy (sensory and motor) less than or equal to CTCAE v3.0 grade 1.
7) Patients must have signed an approved informed consent and authorization permitting release of personal health information. Current FDA, NCI, and institutional regulations concerning informed consent will be followed.
8) Patients must meet pre-entry requirements.
9) Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception.
10) Patients must have the ability to take folic acid, Vitamin B12, and dexamethasone according to protocol.
11) Patients taking NSAIDs must interrupt dosing for 2-5 days before beginning treatment with pemetrexed. |