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| Sponsors and Collaborators: |
ImClone LLC Bristol-Myers Squibb |
|---|---|
| Information provided by: | ImClone LLC |
| ClinicalTrials.gov Identifier: | NCT00083720 |
Purpose
This is a phase II, multicenter, open-label study of cetuximab in patients with EGFR-undetectable, metastatic colorectal carcinoma who have progressed after receiving at least one standard chemotherapeutic regimen that included a fluoropyrimidine. Target enrollment is 80 evaluable patients.
Patients with EGFR-undetectable metastatic colorectal carcinoma who have progressed after receiving at least one standard chemotherapeutic regimen that included a fluoropyrimidine, will receive an initial dose of cetuximab, 400 mg/m2 , intravenously (i.v.) over 120 minutes, followed by weekly treatment with cetuximab, 250 mg/m2 i.v. over 60 minutes. Patients who experience unacceptable toxicity or who have progressive disease will not receive further cetuximab therapy.
Patients will be evaluated for a tumor response at a minimum of every 6 weeks while on cetuximab therapy. Patients with stable disease or a partial or complete response may continue to receive weekly cetuximab therapy, unless they are dose-delayed or discontinued because of toxicity. Patients who have a partial or complete response must have a confirmatory tumor assessment no less than 4 weeks after the initial evaluation demonstrating a response. To evaluate the objective response rate, a single-stage design will be used in this study.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Neoplasms Metastases Neoplasm |
Biological: Erbitux ™ (cetuximab) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II Multicenter Study of Erbitux (Cetuximab) in Patients With Refractory, EGFR-Negative Metastatic Colorectal Carcinoma |
| Enrollment: | 87 |
| Study Start Date: | September 2004 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Cetuximab: Experimental
Cetuximab at an initial dose of 400 mg/m2 intravenously (i.v.) over 120 minutes, followed by 250 nig/m2 weekly i.v. over 60 minutes
|
Biological: Erbitux ™ (cetuximab)
Cetuximab at an initial dose of 400 mg/m2 intravenously (i.v.) over 120 minutes, followed by 250 nig/m2 weekly i.v. over 60 minutes
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients who do not have tumor tissue available for EGFR testing will undergo biopsy of accessible tumor. A reference laboratory designated by ImClone will perform the EGFR assay.
Exclusion Criteria:
Contacts and Locations
Show 27 Study Locations| Study Director: | Paul Windt, PharmD | ImClone LLC |
More Information
| Responsible Party: | ImClone Systems Incorporated ( Eric Rowinsky/ Chief Medical Officer ) |
| Study ID Numbers: | CP02-0451 |
| Study First Received: | May 28, 2004 |
| Last Updated: | January 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00083720 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
EGFR-undetectable Metastatic Colorectal Cancer |
|
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Cetuximab Colonic Diseases Rectal Neoplasm Intestinal Diseases Rectal Diseases |
Intestinal Neoplasms Carcinoma Digestive System Diseases Rectal Cancer Neoplasm Metastasis Gastrointestinal Neoplasms Colorectal Neoplasms |
|
Digestive System Neoplasms Antineoplastic Agents Gastrointestinal Diseases Cetuximab Colonic Diseases Intestinal Diseases Rectal Diseases Pharmacologic Actions Intestinal Neoplasms |
Neoplasms Neoplastic Processes Pathologic Processes Neoplasms by Site Digestive System Diseases Therapeutic Uses Neoplasm Metastasis Gastrointestinal Neoplasms Colorectal Neoplasms |