Cetuximab in Treating Patients With Persistent or Recurrent Cervical Cancer
Condition: Cervical Squamous Cell Carcinoma; Recurrent Cervical Carcinoma
MeSH terms: Carcinoma; Recurrence
Intervention: Cetuximab
Intervention description: Given IV
Intervention MeSH terms: Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying cetuximab to see how well it works in treating patients with
      persistent or recurrent cervical cancer. Monoclonal antibodies, such as cetuximab, can block
      tumor growth in different ways. Some block the ability of tumor cells to grow and spread.
      Others find tumor cells and help kill them or carry tumor-killing substances to them.
    

Eligibility criteria:

        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 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

          -  Exclusion criteria:

               -  Patients who have received prior therapy with cetuximab or any other
                  anti-epidermal growth factor receptor antibody

               -  Patients who have received any prior therapy with a tyrosine kinase inhibitor
                  that 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 abdominal
                  cavity or pelvis other than for the treatment of cervical cancer within the last
                  five years are excluded

                    -  Prior radiation for localized cancer of the breast, head and neck, or skin
                       is permitted, provided that it was completed more than three years prior to
                       registration and the patient remains free of recurrent or metastatic disease

               -  Patients who have received prior chemotherapy for any abdominal or pelvic tumor
                  other than for the treatment of cervical cancer within the last five years are
                  excluded

                    -  Patients may have received prior adjuvant chemotherapy for localized breast
                       cancer, provided that it was completed more than three years prior to
                       registration and that the patient remains free of recurrent or metastatic
                       disease

               -  Patients who have undergone major surgery, excluding diagnostic biopsy, within 30
                  days (to allow for full recovery) prior to registration