Cetuximab in Treating Patients With Persistent or Recurrent Cervical Cancer

Completed · Phase 2

Conditions studied: Cervical Squamous Cell Carcinoma, Recurrent Cervical Carcinoma

In brief

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.

Key facts

Study ID

NCT00499031

Run by

Gynecologic Oncology Group

People needed

38

Starts

2007-06-01

Last updated by the study team

2015-01-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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:

Where it is running

• Colorado Gynecologic Oncology Group — Aurora, Colorado, United States
• The Hospital of Central Connecticut — New Britain, Connecticut, United States
• Decatur Memorial Hospital — Decatur, Illinois, United States
• Saint Vincent Hospital and Health Services — Indianapolis, Indiana, United States
• Singing River Hospital — Pascagoula, Mississippi, United States
• CoxHealth South Hospital — Springfield, Missouri, United States
• Island Gynecologic Oncology — Brightwaters, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Akron General Medical Center — Akron, Ohio, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Riverside Methodist Hospital — Columbus, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Cancer Care Associates-Midtown — Tulsa, Oklahoma, United States
• Tulsa Cancer Institute — Tulsa, Oklahoma, United States
• Abington Memorial Hospital — Abington, Pennsylvania, United States
• Women and Infants Hospital — Providence, Rhode Island, United States
• AnMed Health Hospital — Anderson, South Carolina, United States
• M D Anderson Cancer Center — Houston, Texas, United States
• Froedtert and the Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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