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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: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
| Experimental: 400 mg/m2 |
Biological: Cetuximab
400 mg/m2 loading dose Week 1, followed by 250 mg/m2 weekly until disease progression
Other Name: Erbitux
|
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
Show 29 Study Locations| Study Chair: | E-mail: ClinicalTrials@ ImClone.com | ImClone LLC |
More Information
| Responsible Party: | Chief Medical Officer, ImClone LLC |
| ClinicalTrials.gov Identifier: | NCT00055419 History of Changes |
| Other Study ID Numbers: | CA225-041 |
| Study First Received: | February 28, 2003 |
| Last Updated: | April 8, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Stage IV colorectal cancer |
|
Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases |
Colonic Diseases Intestinal Diseases Rectal Diseases Cetuximab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |