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Sponsors and Collaborators: |
Massachusetts General Hospital Beth Israel Deaconess Medical Center Dana-Farber Cancer Institute Genentech |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00307736 |
The purpose of this study is determine the safety of 5-fluorouracil, bevacizumab and erlotinib when administered in combination with external beam radiation therapy(Phase I portion) as well as to begin to collect information about whether this combination treatment is effective in treating(Phase II portion) patients with locally advanced rectal cancer.
Condition | Intervention | Phase |
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Rectal Cancer Adenocarcinoma of the Rectum |
Drug: 5-fluorouracil Drug: bevacizumab Drug: erlotinib Procedure: External beam radiation therapy (EBRT) |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Study of Bevacizumab, Erlotinib and 5-Fluorouracil With Concurrent External Beam Radiation Therapy in Locally Advanced Rectal Cancer |
Estimated Enrollment: | 32 |
Study Start Date: | May 2006 |
Estimated Primary Completion Date: | May 2009 (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: Lawrence S. Blaszkowsky, MD | 617-724-4637 |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Lawrence S. Blaszkowsky, MD | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Lawrence Blaszkowsky, MD ) |
Study ID Numbers: | 05-345 |
Study First Received: | March 24, 2006 |
Last Updated: | February 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00307736 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Fluorouracil bevacizumab erlotinib external beam radiation therapy EBRT |
Antimetabolites Erlotinib Digestive System Neoplasms Immunologic Factors Rectal Neoplasms Gastrointestinal Diseases Rectal Neoplasm Bevacizumab Intestinal Diseases Protein Kinase Inhibitors Angiogenesis Inhibitors |
Immunosuppressive Agents Rectal Diseases Intestinal Neoplasms Carcinoma Digestive System Diseases Rectal Cancer Fluorouracil Gastrointestinal Neoplasms Adenocarcinoma Colorectal Neoplasms Neoplasms, Glandular and Epithelial |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Rectal Neoplasms Antineoplastic Agents Physiological Effects of Drugs Bevacizumab Protein Kinase Inhibitors Rectal Diseases Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |
Erlotinib Digestive System Neoplasms Neoplasms by Histologic Type Growth Substances Enzyme Inhibitors Intestinal Diseases Angiogenesis Inhibitors Immunosuppressive Agents Intestinal Neoplasms Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms |