Cetuximab in Treating Patients With Persistent or Recurrent Cervical Cancer

Inclusion Criteria

• 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
• Exclusion criteria:
• Patients with craniospinal metastases
• Inclusion criteria:
• 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
• Exclusion criteria:
• Patients with a history of other invasive malignancies, with the exception of nonmelanoma skin cancer and other specific malignancies, are excluded if there is any evidence of other malignancy being present within the last five years
• Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
• Patients who have a significant history of cardiac disease (i.e., uncontrolled hypertension, unstable angina, uncontrolled congestive heart failure, or uncontrolled arrhythmias) within 6 months of registration
• Patients who have an uncontrolled seizure disorder or active neurological disease
• Patients known to be seropositive for HIV and active hepatitis, even if liver function studies are in the eligible range
• Pregnant or nursing women or women of childbearing potential unless using effective contraception as determined by the investigator
• Known hemorrhagic diathesis or active bleeding disorder
• Inclusion criteria:
• 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