Revised Protocol 07 to Protocol CA225006 - A Phase III Randomized, Open-Label, Multicenter Study of Irinotecan and Cetuximab vs. Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Carcinoma
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer
Both
Colorectal Cancer
Trial Information
Revised Protocol 07 to Protocol CA225006 - A Phase III Randomized, Open-Label, Multicenter Study of Irinotecan and Cetuximab vs. Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Carcinoma
Inclusion Criteria:
- Histologically documented colorectal cancer which is EGFR-positive by
immunohistochemistry [IHC] (may be based on archival samples) and is metastatic.
- Prior oxaliplatin administered for the first-line treatment of metastatic colorectal
cancer.
- Prior fluoropyrimidine-containing regimen (5-fluorouracil [5-FU], capecitabine, or
uracil/tegafur [UFT]), for the first-line treatment of metastatic disease.
Exclusion Criteria:
- A serious uncontrolled medical disorder that, in the opinion of the Investigator,
would impair the ability of the subject to receive protocol therapy
- Unresolved diarrhea, bowel obstruction, or history of inflammatory bowel disease
- Known or documented brain metastases
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival
Outcome Time Frame:
Every 3 months after subject off-treatment
Safety Issue:
No
Principal Investigator
E-mail: ClinicalTrials@ ImClone.com
Investigator Role:
Study Chair
Investigator Affiliation:
ImClone LLC
Authority:
United States: Food and Drug Administration
Study ID:
CA225-006
NCT ID:
NCT00063141
Start Date:
April 2003
Completion Date:
October 2007
Related Keywords:
- Colorectal Cancer
- Colorectal Neoplasms
Name | Location |
|---|---|
| ImClone Investigational Site | Denver, Colorado 80262 |
| ImClone Investigational Site | Greenwich, Connecticut 06830 |
| ImClone Investigational Site | Indianapolis, Indiana 46202 |
| ImClone Investigational Site | New York, New York 10021 |
| ImClone Investigational Site | St. Charles, Missouri 63301 |
| ImClone Investigational Site | Bakersfield, California 93309 |
| ImClone Investigational Site | Jacksonville, Florida 32207 |
| ImClone Investigational Site | Atlanta, Georgia 30318 |
| ImClone Investigational Site | Decatur, Illinois 62526 |
| ImClone Investigational Site | Louisville, Kentucky 40202 |
| ImClone Investigational Site | New Orleans, Louisiana 70121 |
| ImClone Investigational Site | Baltimore, Maryland 21204 |
| ImClone Investigational Site | Ypsilanti, Michigan 48198 |
| ImClone Investigational Site | Minneapolis, Minnesota 55416 |
| ImClone Investigational Site | Voorhees, New Jersey 08043 |
| ImClone Investigational Site | Cleveland, Ohio 44134 |
| ImClone Investigational Site | Greenville, South Carolina 29605 |
| ImClone Investigational Site | Memphis, Tennessee 38104 |
| ImClone Investigational Site | Dallas, Texas 75230 |
| ImClone Investigational Site | Norfolk, Virginia 23502 |
| ImClone Investigational Site | Green Bay, Wisconsin 54307 |
| ImClone Investigational Site | Little Rock, Arkansas 72205 |
| ImClone Investigational Site | Winston-Salem, North Carolina 27103 |
| ImClone Investigational Site | Bismarck, North Dakota 58501 |
| ImClone Investigational Site | Philadelphia, Pennsylvania 19107 |
| ImClone Investigational Site | Ogden, Utah 84403 |
| ImClone Investigational Site | Tucson, Arizona 85712 |
| ImClone Investigational Site | Honolulu, Hawaii 96813 |
| ImClone Investigational Site | Kansas City, Kansas 66160 |
| ImClone Investigational Site | Boston, Massachusetts 02135 |
| ImClone Investigational Site | Jackson, Mississippi 39202 |
| ImClone Investigational Site | Oklahoma City, Oklahoma 73118 |
| ImClone Investigational Site | Seattle, Washington 98104 |
