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Sponsors and Collaborators: |
University of Medicine and Dentistry New Jersey Cancer Institute of New Jersey Bristol-Myers Squibb |
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Information provided by: | University of Medicine and Dentistry New Jersey |
ClinicalTrials.gov Identifier: | NCT00251186 |
This is a Phase II clinical trial measuring the effectiveness of the combination of Capecitabine and cetuximab for first line treatment of colorectal cancer in elderly patients and/or those with multiple comorbidities unable to receive standard chemotherapy. This study will be open approximately 2-3 years. Approximately 36 patients will be enrolled on this study. The study will begin enrolling at The Cancer Institute of New Jersey, with 17 patients in the first group. If more than 4 responses are noted, the accrual will continue to 36 patients throughout CINJOG.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: Capecitabine and Cetuximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | Phase II Study of First-Line Capecitabine and Cetuximab for Treatment of Metastatic Colorectal Cancer in Elderly Patients and/or Those With Multiple Comorbidities Unable to Receive Chemotherapy Doublets |
Estimated Enrollment: | 18 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | April 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Laboratory values showing adequate organ function prior to going on-study:
Exclusion Criteria
United States, New Jersey | |
The Cancer Institute of New Jersey | |
New Brunswick, New Jersey, United States, 08901 |
Principal Investigator: | Elizabeth Poplin, MD | University of Medicine and Dentistry New Jersey |
Study ID Numbers: | 5536, CINJ 070502 |
Study First Received: | November 7, 2005 |
Last Updated: | July 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00251186 |
Health Authority: | United States: Food and Drug Administration |
Capecitabine Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Cetuximab Colonic Diseases |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |