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
- 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
- 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
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
Masking: Open Label, Primary Purpose: Treatment
Antitumor activity as assessed by RECIST criteria every 4 weeks
John H. Farley, MD
Uniformed Services University of the Health Sciences
United States: Federal Government
|MetroHealth Cancer Care Center at MetroHealth Medical Center||Cleveland, Ohio 44109|
|Providence Saint Joseph Medical Center - Burbank||Burbank, California 91505|
|University of Texas Medical Branch||Galveston, Texas 77555-1329|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center||Kansas City, Kansas 66160-7353|
|Cancer Care Associates - Midtown Tulsa||Tulsa, Oklahoma 74104|
|Ochsner Cancer Institute at Ochsner Clinic Foundation||New Orleans, Louisiana 70121|
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|
|Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center||Savannah, Georgia 31403-3089|
|Indiana University Melvin and Bren Simon Cancer Center||Indianapolis, Indiana 46202-5289|
|University of Mississippi Cancer Clinic||Jackson, Mississippi 39216-4505|
|Oklahoma University Cancer Institute||Oklahoma City, Oklahoma 73104|
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|
|Fox Chase Virtua Health Cancer Program at Virtua West Jersey||Voorhees, New Jersey 08043|
|Fox Chase Cancer Center - Philadelphia||Philadelphia, Pennsylvania 19111-2497|
|McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center||Reading, Pennsylvania 19612-6052|
|Christus Schumpert Cancer Treatment Center||Shreveport, Louisiana 71101|