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
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Antitumor activity as assessed by RECIST criteria every 4 weeks
No
John H. Farley, MD
Study Chair
Uniformed Services University of the Health Sciences
United States: Federal Government
CDR0000405839
NCT00101192
September 2004
Name | Location |
---|---|
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 |