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Sponsors and Collaborators: |
ImClone Systems Bristol-Myers Squibb |
Information provided by: | ImClone Systems |
ClinicalTrials.gov Identifier: | NCT00083720 |
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 |
Drug: Erbitux ™ (cetuximab) |
Phase II |
MedlinePlus related topics: | Cancer Colorectal Cancer |
ChemIDplus related topics: | Cetuximab |
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 |
Estimated Enrollment: | 80 |
Study Start Date: | September 2004 |
Study Completion Date: | August 2007 |
Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: 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
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Drug: 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
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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:
Show 27 Study Locations |
ImClone Systems |
Bristol-Myers Squibb |
Study Director: | Paul Windt, PharmD | ImClone Systems |
Responsible Party: | ImClone Systems Incorporated ( Polina Binder, MD/ Medical Director, Drug Safety ) |
Study ID Numbers: | CP02-0451 |
First Received: | May 28, 2004 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00083720 |
Health Authority: | United States: Food and Drug Administration |
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