Cetuximab in Treating Patients With Persistent or Recurrent Cervical Cancer

Inclusion Criteria

• •* Patients must have persistent or recurrent squamous or non-squamous cell carcinoma of the cervix with documented disease progression (disease not amenable to curative therapy)
• •* Histologic documentation of the original primary tumor is required via the pathology report
• •* All patients must have measurable disease 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 scan, and MRI, OR ≥ 10 mm when measured by spiral CT scan
• •* Patients must have at least one target lesion to be used to assess response on this protocol
• •* Tumors within a previously irradiated field will be designated as nontarget lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
• •* Patients must have had one prior systemic chemotherapeutic regimen for management of advanced, metastatic, or recurrent carcinoma of the cervix
• •* Chemotherapy administered in conjunction with primary radiation as a radiosensitizer is not counted as a systemic chemotherapy regimen
• •* 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
• •* Patients who have received one prior regimen must have a GOG performance status of 0, 1, or 2 or patients who have received two prior regimens must have a GOG performance status of 0 or 1
• •* Patients should be free of active infection requiring antibiotics
• •* Platelet count ≥ 100,000/μl
• •* ANC ≥ 1,500/μl
• •* Creatinine ≤ 1.5 x institutional upper limit normal (ULN)
• •* Bilirubin ≤ 1.5 x ULN
• •* SGOT and alkaline phosphatase ≤ 2.5 x ULN
• •* Neuropathy (sensory and motor) ≤ CTCAE v3.0 grade 1
• •* Calcium \< 11.0 mg/dL
• •* Patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to initiating protocol therapy and be practicing an effective form of contraception during protocol therapy and for at least two months following completion of protocol therapy
• •* Recovery from effects of recent surgery, radiotherapy, or chemotherapy
• •* 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)
• •* Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least three weeks prior to registration
• •* Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent cervical disease according to the following definition:
• •* Cytotoxic regimens include any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa
• •* Patients must not have received any non-cytotoxic therapy for management of recurrent or persistent cervical disease
• •* Patients must not be receiving any other investigational agent