Cetuximab and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
- Conditions
- Cervical Cancer
- Registration Number
- NCT00101192
- Lead Sponsor
- Gynecologic Oncology Group
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 76
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tumor Response up to 6 months from study entry 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.
- Secondary Outcome Measures
Name Time Method Progression-free Survival and Overall Survival at 6 Months After Completion of Treatment up to 5 years from study entry
Trial Locations
- Locations (18)
Fox Chase Cancer Center - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
University of Mississippi Cancer Clinic
🇺🇸Jackson, Mississippi, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Oklahoma University Cancer Institute
🇺🇸Oklahoma City, Oklahoma, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
🇺🇸Voorhees, New Jersey, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
🇺🇸Reading, Pennsylvania, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Providence Saint Joseph Medical Center - Burbank
🇺🇸Burbank, California, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center
🇺🇸Cleveland, Ohio, 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
M. D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States
Christus Schumpert Cancer Treatment Center
🇺🇸Shreveport, Louisiana, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Cancer Care Associates - Midtown Tulsa
🇺🇸Tulsa, Oklahoma, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States