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Sponsors and Collaborators: |
University of Pennsylvania Bristol-Myers Squibb Hoffmann-La Roche |
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Information provided by: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT00353457 |
This is a phase II study of induction chemotherapy (capecitabine, oxaliplatin and cetuximab (erbitux)) followed by capecitabine, oxaliplatin, cetuximab and radiotherapy followed by surgery followed by adjuvant capecitabine, oxaliplatin and cetuximab for locally advanced resectable rectal cancer.
Condition | Intervention | Phase |
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Rectal Cancer |
Drug: Capecitabine, Oxaliplatin and Cetuximab Radiation: Radiation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment |
Official Title: | Phase II Study of Capecitabine, Oxaliplatin and Cetuximab Given Throughout Multi-Modal Therapy for Locally Advanced Rectal Adenocarcinoma |
Estimated Enrollment: | 40 |
Study Start Date: | February 2006 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lauren Mennine, RN, BSN | 215-349-8913 | lauren.mennine@uphs.upenn.edu |
United States, Pennsylvania | |
Abramson Cancer Center at University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Daniel G Haller, M.D. | Abramson Cancer Center of University of Pennsylvania |
Principal Investigator: | James M Metz, M.D. | Abramson Cancer Center of University of Pennsylvania |
Responsible Party: | University of Pennsylvania ( Daniel Haller, MD ) |
Study ID Numbers: | 803437, UPCC 09204 |
Study First Received: | July 14, 2006 |
Last Updated: | February 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00353457 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Adjuvant therapy Rectal cancer Capecitabine |
Oxaliplatin Cetuximab Erbitux |
Antimetabolites Capecitabine Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Cetuximab Adjuvants, Immunologic Rectal Neoplasm Intestinal Diseases Rectal Diseases |
Intestinal Neoplasms Carcinoma Oxaliplatin Digestive System Diseases Rectal Cancer Gastrointestinal Neoplasms Adenocarcinoma Colorectal Neoplasms Neoplasms, Glandular and Epithelial |
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Neoplasms by Histologic Type Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Rectal Neoplasms Gastrointestinal Diseases Cetuximab Intestinal Diseases Rectal Diseases |
Pharmacologic Actions Intestinal Neoplasms Carcinoma Oxaliplatin Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Adenocarcinoma Colorectal Neoplasms Neoplasms, Glandular and Epithelial |