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| Sponsor: | Dana-Farber Cancer Institute |
|---|---|
| Collaborators: |
Brigham and Women's Hospital Massachusetts General Hospital Genentech |
| Information provided by: | Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01191697 |
Purpose
The purpose of this study is to determine the safety and effectiveness of a combination of chemotherapy, capecitabine and oxaliplatin, plus the antibodies bevacizumab and trastuzumab. Trastuzumab (also called Herceptin) is an antibody that attacks HER2 protein in tumor cells. Bevacizumab (also called Avastin) works by slowing or stopping the growth of cells in cancer tumors by decreasing the blood supply of the tumors. If blood supply is decreased, oxygen and nutrients that are needed for tumor growth are decreased. The chemotherapy used in this trial is called CAPOX, which is an abbreviation of capecitabine and oxaliplatin.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer Gastric Cancer |
Drug: bevacizumab Drug: trastuzumab Drug: oxaliplatin Drug: capecitabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of CAPOX, Bevacizumab and Trastuzumab for Patients With HER2-Positive Metastatic Esophagogastric Cancer |
| Estimated Enrollment: | 36 |
| Study Start Date: | December 2010 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Part II: Patient must have primary esophagogastric tumor in place or other tumor that is accessible for mandatory biopsy.
Exclusion Criteria:
Contacts and Locations| Contact: GI Research Line | 617-632-5960 | |
| Contact: Eileen Regan, RN, OCN | 617-632-3898 | eileen_regan@dfci.harvard.edu |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: Peter Enzinger, MD | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: Eunice Kwak, MD | |
| Principal Investigator: | Peter Enzinger, MD | Dana-Farber Cancer Institute |
More Information
| Responsible Party: | Peter C. Enzinger, MD, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01191697 History of Changes |
| Other Study ID Numbers: | 09-457 |
| Study First Received: | August 27, 2010 |
| Last Updated: | September 15, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
HER2 positive |
|
Esophageal Diseases Esophageal Neoplasms Stomach Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Stomach Diseases Oxaliplatin Trastuzumab |
Capecitabine Bevacizumab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |