Cetuximab and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Limited Access Phase II Trial of Cetuximab (C225, NSC #714692) in Combination With Cisplatin (NSC #119875) in the Treatment of Advanced, Persistent, or Recurrent Carcinoma of the Cervix|
- Tumor Response [ Time Frame: up to 6 months from study entry ] [ Designated as safety issue: No ]
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.
- Progression-free Survival and Overall Survival at 6 Months After Completion of Treatment [ Time Frame: up to 5 years from study entry ] [ Designated as safety issue: No ]
|Study Start Date:||September 2004|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00101192
|United States, California|
|Providence Saint Joseph Medical Center - Burbank|
|Burbank, California, United States, 91505|
|USC/Norris Comprehensive Cancer Center and Hospital|
|Los Angeles, California, United States, 90089-9181|
|United States, Georgia|
|Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center|
|Savannah, Georgia, United States, 31403-3089|
|United States, Indiana|
|Indiana University Melvin and Bren Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202-5289|
|United States, Kansas|
|Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160-7357|
|United States, Louisiana|
|Ochsner Cancer Institute at Ochsner Clinic Foundation|
|New Orleans, Louisiana, United States, 70121|
|Christus Schumpert Cancer Treatment Center|
|Shreveport, Louisiana, United States, 71101|
|United States, Mississippi|
|University of Mississippi Cancer Clinic|
|Jackson, Mississippi, United States, 39216|
|United States, New Jersey|
|Fox Chase Virtua Health Cancer Program at Virtua West Jersey|
|Voorhees, New Jersey, United States, 08043|
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|MetroHealth Cancer Care Center at MetroHealth Medical Center|
|Cleveland, Ohio, United States, 44109|
|United States, Oklahoma|
|Oklahoma University Cancer Institute|
|Oklahoma City, Oklahoma, United States, 73104|
|Cancer Care Associates - Midtown Tulsa|
|Tulsa, Oklahoma, United States, 74104|
|United States, Pennsylvania|
|Fox Chase Cancer Center - Philadelphia|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center|
|Reading, Pennsylvania, United States, 19612-6052|
|United States, Texas|
|University of Texas Medical Branch|
|Galveston, Texas, United States, 77555-0361|
|M. D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||John H. Farley, MD||Uniformed Services University of the Health Sciences|