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| Sponsor: | ImClone LLC |
|---|---|
| Collaborator: |
Bristol-Myers Squibb |
| Information provided by: | ImClone LLC |
| ClinicalTrials.gov Identifier: | NCT00055419 |
Purpose
The purpose of this clinical research study is to learn about the safety of cetuximab in patients with stage IV colorectal cancer, and who may benefit from cetuximab.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Neoplasms |
Biological: Cetuximab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | A Phase II Study of Cetuximab in Patients Who Have Stage IV Colorectal Cancer |
| Enrollment: | 744 |
| Study Start Date: | February 2003 |
| Study Completion Date: | August 2004 |
| Primary Completion Date: | July 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 400 mg/m2: Experimental |
Biological: Cetuximab
400 mg/m2 loading dose Week 1, followed by 250 mg/m2 weekly until disease progression
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, California | |
| Comprehensive Blood and Cancer Center | |
| Bakersfield, California, United States | |
| Cancer Institute Medical Group | |
| Los Angeles, California, United States | |
| United States, Colorado | |
| Rocky Mountain Cancer Center | |
| Denver, Colorado, United States | |
| United States, Connecticut | |
| Northwestern Connecticut Oncology/Hemaology Associates | |
| Torrington, Connecticut, United States | |
| United States, District of Columbia | |
| Georgetown Univerisity Medical Center | |
| Washington, District of Columbia, United States | |
| United States, Florida | |
| Oncology Hematology Group of South Florida | |
| Miami, Florida, United States | |
| Hematology and Oncology Consultants | |
| Orlando, Florida, United States | |
| Florida Oncology Asociates | |
| Jacksonville, Florida, United States | |
| United States, Georgia | |
| Peachtree Hematology and Oncology | |
| Atlanta, Georgia, United States | |
| United States, Illinois | |
| Decatur Memorial Hospital | |
| Decatur, Illinois, United States | |
| United States, Kentucky | |
| Kentuckianna Cancer Institute | |
| Louisville, Kentucky, United States | |
| United States, Louisiana | |
| Ochsner Cancer Center | |
| New Orleans, Louisiana, United States | |
| United States, Maryland | |
| Greater Baltimore Medical Center | |
| Baltimore, Maryland, United States | |
| United States, Michigan | |
| McCauley Cancer Center | |
| Ypsilanti, Michigan, United States | |
| United States, Minnesota | |
| Park Nicollet Cancer Center | |
| Minneapolis, Minnesota, United States, 55416 | |
| United States, Missouri | |
| Missouri Cancer Care | |
| St Charles, Missouri, United States | |
| United States, Montana | |
| Benefits Healthcare Hospital | |
| Great Falls, Montana, United States | |
| United States, Nevada | |
| Nevada Cancer Center | |
| Las Vegas, Nevada, United States, 89109 | |
| United States, New Jersey | |
| Cooper Health System Cancer Center | |
| Voorhees, New Jersey, United States | |
| United States, New York | |
| NYOH | |
| Latham, New York, United States | |
| North Shore Hematology Oncology Associates | |
| East Setauket, New York, United States | |
| New York University Medical Center | |
| New York City, New York, United States | |
| United States, Ohio | |
| University Hospitals of Cleveland | |
| Cleveland, Ohio, United States | |
| United States, Oregon | |
| Oregon Hematology Oncology Associates, P.C. | |
| Portland, Oregon, United States | |
| United States, South Carolina | |
| Cancer Centers of the Carolinas | |
| Greenville, South Carolina, United States | |
| United States, Tennessee | |
| Memphis Cancer Center | |
| Memphis, Tennessee, United States | |
| United States, Texas | |
| Center for Oncology Research and Treatment | |
| Dallas, Texas, United States | |
| United States, Virginia | |
| Virginia Oncology Associates-Mid-Atlantic Consultants in Hem/Onc | |
| Norfolk, Virginia, United States | |
| United States, Wisconsin | |
| Green Bay Oncology | |
| Green Bay, Wisconsin, United States | |
More Information
| Responsible Party: | ImClone LLC ( Eric Rowinsky/ Chief Medical Officer ) |
| Study ID Numbers: | CA225-041 |
| Study First Received: | February 28, 2003 |
| Last Updated: | August 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00055419 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Stage IV colorectal cancer |
|
Digestive System Neoplasms Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Cetuximab Intestinal Diseases Rectal Diseases Pharmacologic Actions |
Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Colorectal Neoplasms |