Cetuximab and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
Cervical Cancer
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring recurrent cervical cancer, cervical adenocarcinoma, cervical adenosquamous cell carcinoma, cervical small cell carcinoma, cervical squamous cell carcinoma, stage III cervical cancer, stage IVA cervical cancer, stage IVB cervical cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed squamous or non-squamous cell carcinoma of the cervix Advanced, persistent, or recurrent disease Documented disease progression Not amenable to curative therapy Measurable disease At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan At least 1 target lesion Tumors within a previously irradiated field are designated as non-target lesions unless progression is documented or a biopsy is obtained ≥ 90 days after completion of radiotherapy to confirm persistence PATIENT CHARACTERISTICS: Age 18 and over Performance status GOG 0-2 Life expectancy Not specified Hematopoietic Platelet count ≥ 100,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) AST ≤ 2.5 times ULN Alkaline phosphatase ≤ 2.5 times ULN Renal Creatinine ≤ 1.5 times ULN Cardiovascular No significant history of cardiac disease within the past 6 months, including the following: Unstable angina Uncontrolled hypertension Uncontrolled congestive heart failure Uncontrolled arrhythmia Neurologic No uncontrolled seizure disorder No active neurological disease No neuropathy (sensory and motor) > grade 1 Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infection requiring antibiotics No other invasive malignancy within the past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy No prior anti-epidermal growth factor receptor (EGFR) antibody therapy No prior chimerized or murine monoclonal antibody therapy Chemotherapy Not specified Endocrine therapy At least 1 week since prior anticancer hormonal therapy Concurrent hormone replacement therapy allowed Radiotherapy See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery More than 30 days since prior major surgery, except diagnostic biopsy Other Recovered from all prior therapy No prior cytotoxic therapy for cervical cancer No prior tyrosine kinase inhibitor therapy that targets the EGFR pathway No prior cancer treatment that would contraindicate study therapy No other concurrent investigational agents
Sites / Locations
- Providence Saint Joseph Medical Center - Burbank
- USC/Norris Comprehensive Cancer Center and Hospital
- Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- Indiana University Melvin and Bren Simon Cancer Center
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- Ochsner Cancer Institute at Ochsner Clinic Foundation
- Christus Schumpert Cancer Treatment Center
- University of Mississippi Cancer Clinic
- Fox Chase Virtua Health Cancer Program at Virtua West Jersey
- Wake Forest University Comprehensive Cancer Center
- MetroHealth Cancer Care Center at MetroHealth Medical Center
- Cleveland Clinic Taussig Cancer Center
- Oklahoma University Cancer Institute
- Cancer Care Associates - Midtown Tulsa
- Fox Chase Cancer Center - Philadelphia
- McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
- University of Texas Medical Branch
- M. D. Anderson Cancer Center at University of Texas