RATIONALE: 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. Cetuximab may also help cisplatin work better by making tumor cells more sensitive to the drug. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with cisplatin may be a better way to block tumor growth. PURPOSE: This phase II trial is studying how well giving cetuximab together with cisplatin works in treating patients with advanced, persistent, or recurrent cervical cancer.
OBJECTIVES: Primary * Determine the antitumor activity of cetuximab and cisplatin, in terms of objective tumor response (partial and complete), in patients with advanced, persistent, or recurrent carcinoma of the cervix. * Determine the nature and degree of toxicity of this regimen in these patients. Secondary * Determine the progression-free survival and overall survival of patients treated with this regimen. * Correlate epidermal growth factor receptor expression with progression-free survival, overall survival, and response in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and cisplatin IV on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 28-62 patients will be accrued for this study within 9-20 months.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Christus Schumpert Cancer Treatment Center
Shreveport, Louisiana, United States
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees Township, New Jersey, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
...and 8 more locations
Tumor Response
Per GOG Response Evaluation Criteria In Solid Tumors(RECIST) Criteria: Complete Response(CR): disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response(PR): at least a 30% decrease in the sum of longest dimensions(LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Increasing Disease: at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Stable Disease: any condition not meeting the above criteria. Indeterminate for response: as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.
Time frame: up to 6 months from study entry
Progression-free Survival and Overall Survival at 6 Months After Completion of Treatment
Time frame: up to 5 years from study entry
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