Cetuximab in Treating Patients With Persistent or Recurrent Cervical Cancer

Inclusion Criteria:

• Inclusion criteria:

• Patients must have persistent or recurrent squamous or non-squamous cellcarcinoma of the cervix with documented disease progression (disease not amenableto curative therapy)

• Histologic documentation of the original primary tumor is required via thepathology report

• All patients must have measurable disease defined as at least one lesion that canbe accurately measured in at least one dimension (longest dimension to berecorded)

• Each lesion must be ≥ 20 mm when measured by conventional techniques,including palpation, plain x-ray, CT scan, and MRI, OR ≥ 10 mm when measuredby spiral CT scan

• Patients must have at least one target lesion to be used to assess response onthis protocol

• Tumors within a previously irradiated field will be designated as nontargetlesions unless progression is documented or a biopsy is obtained to confirmpersistence at least 90 days following completion of radiation therapy

• Patients must have had one prior systemic chemotherapeutic regimen for managementof advanced, metastatic, or recurrent carcinoma of the cervix

• Chemotherapy administered in conjunction with primary radiation as aradiosensitizer 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 thesame patient population

• Exclusion criteria:

• Patients with craniospinal metastases

• Inclusion criteria:

• Patients who have received one prior regimen must have a GOG performance statusof 0, 1, or 2 or patients who have received two prior regimens must have a GOGperformance 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 testwithin 7 days prior to initiating protocol therapy and be practicing an effectiveform of contraception during protocol therapy and for at least two monthsfollowing completion of protocol therapy

• Exclusion criteria:

• Patients with a history of other invasive malignancies, with the exception ofnonmelanoma skin cancer and other specific malignancies, are excluded if there isany evidence of other malignancy being present within the last five years

• Patients are also excluded if their previous cancer treatmentcontraindicates this protocol therapy

• Patients who have a significant history of cardiac disease (i.e., uncontrolledhypertension, unstable angina, uncontrolled congestive heart failure, oruncontrolled 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 liverfunction studies are in the eligible range

• Pregnant or nursing women or women of childbearing potential unless usingeffective 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 atleast one week prior to registration (continuation of hormone replacementtherapy is permitted)

• Any other prior therapy directed at the malignant tumor, includingimmunologic agents, must be discontinued at least three weeks prior toregistration

• Patients are allowed to receive, but are not required to receive, one additionalcytotoxic regimen for management of recurrent or persistent cervical diseaseaccording to the following definition:

• Cytotoxic regimens include any agent that targets the genetic and/or mitoticapparatus of dividing cells, resulting in dose-limiting toxicity to the bonemarrow and/or gastrointestinal mucosa

• Patients must not have received any non-cytotoxic therapy for management ofrecurrent or persistent cervical disease

• Patients must not be receiving any other investigational agent

• Exclusion criteria:

• Patients who have received prior therapy with cetuximab or any otheranti-epidermal growth factor receptor antibody

• Patients who have received any prior therapy with a tyrosine kinase inhibitorthat targets the EGFR pathway

• Patients who have received prior chimerized or murine monoclonal antibody therapy

• Patients who have received prior radiotherapy to any portion of the abdominalcavity or pelvis other than for the treatment of cervical cancer within the lastfive years are excluded

• Prior radiation for localized cancer of the breast, head and neck, or skinis permitted, provided that it was completed more than three years prior toregistration and the patient remains free of recurrent or metastatic disease

• Patients who have received prior chemotherapy for any abdominal or pelvic tumorother than for the treatment of cervical cancer within the last five years areexcluded

• Patients may have received prior adjuvant chemotherapy for localized breastcancer, provided that it was completed more than three years prior toregistration and that the patient remains free of recurrent or metastaticdisease

• Patients who have undergone major surgery, excluding diagnostic biopsy, within 30days (to allow for full recovery) prior to registration