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| Sponsor: | ImClone LLC |
|---|---|
| Collaborator: |
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 epidermal growth factor receptor (EGFR) negative, 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-negative 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 (PD) 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 (SD), partial response (PR), or a complete response (CR) may continue to receive weekly cetuximab therapy, unless they are dose-delayed or discontinued because of toxicity. Patients who have a PR or CR 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: 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: | October 2004 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
cetuximab: Experimental
Initial dose of 400 mg/m2 intravenously (i.v.) over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
|
Biological: cetuximab
Initial dose of 400 mg/m2 intravenously (i.v.) over 120 minutes, followed by 250 mg/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:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, California | |
| USC/Norris Comprehensive Cancer Center | |
| Los Angeles, California, United States, 90033 | |
| Southbay Oncology Hematology Partners | |
| Campbell, California, United States, 95008 | |
| The Cancer Prevention and Treatment Center | |
| Soquel, California, United States, 95073 | |
| United States, Florida | |
| Florida Hospital Memorial Division | |
| Ormond Beach, Florida, United States, 32174 | |
| Integrated Community Oncology Network | |
| Jacksonville, Florida, United States, 32256 | |
| Florida Hospital Cancer Institute | |
| Orlando, Florida, United States, 32804 | |
| United States, Illinois | |
| Oncology-Hematology Associates of N IL, Ltd | |
| Gurnee, Illinois, United States, 60031 | |
| United States, Indiana | |
| Indiana University Cancer Center / Indiana University Clarian Health Partners | |
| Indianapolis, Indiana, United States, 46202 | |
| Oncology Hematology Associates of South West Indiana (OHA) | |
| Evansville, Indiana, United States, 47714 | |
| United States, Kentucky | |
| Kentucklana Cancer Center, PLLC | |
| Louisville, Kentucky, United States, 40202 | |
| Lexington Oncology Associates, PSC | |
| Lexington, Kentucky, United States, 40503 | |
| United States, Louisiana | |
| Oncology & Hematology | |
| Metairie, Louisiana, United States, 70006 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| St. Joseph Mercy Hospital | |
| Ann Arbor, Michigan, United States, 48106-0995 | |
| Kalamazoo Hematology and Oncology | |
| Kalamazoo, Michigan, United States, 49048 | |
| United States, Missouri | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| North Shore Hematology Oncology Associates P.C. | |
| East Setauket, New York, United States, 11733 | |
| Advanced Oncology Associates | |
| Armonk, New York, United States, 10504 | |
| United States, North Carolina | |
| Duke University Medical Center / Morris Cancer Center Clinics | |
| Durham, North Carolina, United States, 27710 | |
| United States, Pennsylvania | |
| Cancer Care Center of Central PA | |
| Sellingsgrove, Pennsylvania, United States, 17870 | |
| United States, Texas | |
| Arlington Cancer Center | |
| Arlington, Texas, United States, 76012 | |
| Scott & White Hospital | |
| Temple, Texas, United States, 76508 | |
| Kumud Tripathy, MD | |
| Bryan, Texas, United States, 77802 | |
| Canada, Ontario | |
| DRCC- Lakeridge Health Oshawa | |
| Oshawa, Ontario, Canada, L1G 2B9 | |
| Pricess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Toronto Sunnybrook Regional Cancer Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| The Ottawa Hospital Regional Cancer Centre | |
| Ottawa, Ontario, Canada, K1H 1C4 | |
| Study Director: | Paul Windt, PharmD | ImClone LLC |
More Information
| Responsible Party: | ImClone LLC ( Eric Rowinsky/ Chief Medical Officer ) |
| Study ID Numbers: | CP02-0451 |
| Study First Received: | May 28, 2004 |
| Results First Received: | April 16, 2009 |
| Last Updated: | November 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00083720 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Canada: Ethics Review Committee; Canada: Health Canada |
|
EGFR-undetectable Metastatic Colorectal Cancer |
|
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 |