Cetuximab in Treating Patients With Persistent or Recurrent Cervical Cancer

Not Recruiting

Trial ID: NCT00499031


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.

Official Title

A Phase II Evaluation of Cetuximab (Erbitux®, C225, NSC# 714692) in the Treatment of Persistent or Recurrent Squamous or Non-Squamous Cell Carcinoma of the Cervix

Stanford Investigator(s)

Jonathan S. Berek, MD, MMSc
Jonathan S. Berek, MD, MMSc

Laurie Kraus Lacob Professor


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

         - 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

      - 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

         - 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

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


biological: cetuximab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Maureen Sutton

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