| Inclusion Criteria: | 1) Patients must have persistent or recurrent squamous or non-squamous cell carcinoma of the cervix with documented disease progression. 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 >/= 20mm 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 not be eligible for a higher priority GOG protocol, if one exists. In general, this would refer to any active GOG phase III protocol for the same patient population.
5) Patients must have a GOG performance status of 0, 1, or 2.
6) Patients must have recovered from effects of recent surgery, radiotherapy, or chemotherapy.
7) Patients should be free of active infection requiring antibiotics.
8) Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration. Continuation of hormone replacement therapy is permitted.
9) Any other prior therapy directed at the malignant tumor, including biological and immunologic agents, must be discontinued at least three weeks prior to registration.
10) Patients must have had one prior systemic chemotherapeutic regimen for management of advanced, metastatic, or recurrent squamous or nonsquamous cell carcinoma of the cervix. Chemotherapy administered in conjunction with primary radiation as a radio-sensitizer is not counted as a systemic chemotherapy regimen.
11) Patients must have NOT received more than one previous cytotoxic chemotherapy regimen (either with single or combination cytotoxic drug therapy).
12) Patients are allowed to receive, but are not required to have received, one additional non-cytotoxic regimen for management of recurrent or persistent disease according to the following definition: Non-cytotoxic (biologic or cytostatic) agents include (but are not limited to) monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction.
13) 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.
14) Renal function: creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v3.0 grade 1.
15) Hepatic function: Bilirubin less than or equal to 1.5 x ULN (CTC grade 1). SGOT and alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v3.0 grade 1).
16) Neurologic function: Neuropathy (sensory and motor) less than or equal to CTCAE v3.0 grade 1.
17) Patients must have signed an approved informed consent and authorization permitting the release of personal health information.
18) Pre-treatment evaluation has been completed.
19) Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception. |