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Sponsors and Collaborators: |
Dana-Farber Cancer Institute Brigham and Women's Hospital Massachusetts General Hospital Beth Israel Deaconess Medical Center Genentech Sanofi-Synthelabo |
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Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00116506 |
Despite recent advances, most patients with advanced colorectal cancer continue to have a poor prognosis. 5-FU, leucovorin, oxaliplatin and bevacizumab is a standard treatment option for patients with stage IV colorectal cancer. Fluorouracil (5-FU), leucovorin and oxaliplatin are considered traditional chemotherapies that try to stop tumor growth by affecting how they divide. Bevacizumab is a therapy to try to block the blood vessels that tumors need to grow. It is considered a 'targeted agent'. Erlotinib is another targeted agent, that has been shown to be effective in treating lung and other cancers. This trial is assessing the potential benefit of adding these second targeted agents to standard treatment.
Condition | Intervention | Phase |
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Colorectal Cancer Neoplasm Metastasis |
Drug: erlotinib Drug: FOLFOX Drug: bevacizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Study of Bevacizumab (Avastin™) and Erlotinib (Tarceva™) in Combination With FOLFOX for Patients With Untreated Metastatic Colorectal Cancer |
Estimated Enrollment: | 35 |
Study Start Date: | January 2005 |
Study Completion Date: | July 2007 |
Primary Completion Date: | July 2007 (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:
Adequate hepatic function as evidenced by: *Serum total bilirubin < 1.5 mg/dL; *Alkaline phosphatase < 3X the ULN (< 5X the ULN for patients with known hepatic metastases);
Exclusion Criteria:
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Massachusett General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 |
Principal Investigator: | Jeffrey Meyerhardt, MD | Dana-Farber Cancer Institute |
Study ID Numbers: | 04-365 |
Study First Received: | June 29, 2005 |
Last Updated: | December 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00116506 History of Changes |
Health Authority: | United States: Institutional Review Board |
Metastatic Colorectal Cancer Bevacizumab Erlotinib FOLFOX |
Erlotinib Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Bevacizumab Intestinal Diseases Protein Kinase Inhibitors |
Rectal Diseases Angiogenesis Inhibitors Intestinal Neoplasms Digestive System Diseases Neoplasm Metastasis Gastrointestinal Neoplasms Colorectal Neoplasms |
Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Physiological Effects of Drugs Bevacizumab Rectal Diseases Protein Kinase Inhibitors Neoplastic Processes Neoplasms by Site Pathologic Processes Therapeutic Uses Neoplasm Metastasis Angiogenesis Modulating Agents |
Growth Inhibitors Erlotinib Digestive System Neoplasms Growth Substances Enzyme Inhibitors Intestinal Diseases Angiogenesis Inhibitors Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Colorectal Neoplasms |