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Sponsors and Collaborators: |
Duke University Hoffmann-La Roche Sanofi-Aventis Genentech |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00447330 |
The purpose of this study is to evaluate the progression free survival of Capecitabine, Oxaliplatin and Bevacizumab in previously untreated metastatic esophagogastric adenocarcinomas
Condition | Intervention | Phase |
---|---|---|
Esophageal Neoplasms Stomach Neoplasms Neoplasm Metastasis |
Drug: capecitabine, oxaliplatin and bevacizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase ll Study of Oxaliplatin, Capecitabine, and Bevacizumab in the Treatment of Metastatic Esophagogastric Adenocarcinomas |
Estimated Enrollment: | 37 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: capecitabine, oxaliplatin and bevacizumab
Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle. Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle. Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin. |
The number of new cases of esophageal and gastric cancers in the United States in 2005 is 14520 for esophageal cancer and 21860 for gastric cancer. Unfortunately, esophageal and gastric cancers will also account for 13570 and 11550 deaths, respectively, in 2005. The 5 year survival rates for metastatic gastroesophageal, GE junctional, and gastric cancers are less than 5%. The major current treatment modality for patients with advanced esophageal, GE junctional, and gastric adenocarcinomas is systemic chemotherapy.
We seek to investigate the efficacy of capecitabine and oxaliplatin in combination with bevacizumab as first line treatment for metastatic esophagogastric cancers. The choice of capecitabine and oxaliplatin is made to develop a user-friendly biologically-based regimen, offering patients oral capecitabine in place of continuous 5FU infusion pumps. Since capecitabine can be given crushed this regimen may both be active and user-friendly. Preliminary data in colorectal cancer suggest that the regimen of capecitabine, oxaliplatin, and bevacizumab has comparable activity to FOLFOX-bevacizumab. The goal of the proposed regimen is to define a capecitabine and oxaliplatin-based regimen that optimizes biological approaches over cytotoxic approaches. The addition of bevacizumab to chemotherapy regimens for metastatic colorectal cancer, metastatic non-small cell lung cancer, and metastatic breast cancer has shown to improve response rates and overall survival. If active, this regimen could serve as a first line comparator to the capecitabine, oxaliplatin, and epirubicin combination. This approach will also help to simplify regimen development across gastrointestinal cancers.
In addition to the primary efficacy endpoint of this protocol, several correlative endpoints will also be examined in an exploratory manner. The importance of developing blood-based and tumor biomarkers has been extensively reviewed. However, the role of such predictive markers has not been well studied for XELOX-A. This information is important since it may help define which populations are most likely to benefit and most likely to suffer significant toxicity from this important GI cancer regimen. This biomarker approach may also help understand and define mechanisms of sensitivity, resistance, and toxicity that may be used to guide future hypothesis-driven studies designed to improve the efficacy and safety of this regimen. The correlative biomarker endpoints include serum, plasma and urine biomarkers (e.g. VEGF and bFGF), a wound healing model of angiogenesis, and tumor biopsy studies .
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Amy D Franklin, BA | 919-668-6701 | Amy.Franklin@duke.edu |
Contact: Anthony Amara, MSW | 668-1861 | Anthony.Amara@duke.edu |
United States, North Carolina | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Anthony H Amara, MSW 919-668-1861 anthony.amara@duke.edu | |
Principal Investigator: Hope E Uronis, MD | |
University of Wake Forest Baptist Medical Center | Active, not recruiting |
Winston Salem, North Carolina, United States, 27157-0001 | |
United States, Tennessee | |
Sarah Cannon Research Institute | Recruiting |
Nashville, Tennessee, United States | |
Sub-Investigator: Johanna C Bendell, MD |
Principal Investigator: | Hope E Uronis, MD | Duke University |
Responsible Party: | Duke University Medical Center ( Hope E. Uronis, MD ) |
Study ID Numbers: | 8797 |
Study First Received: | March 13, 2007 |
Last Updated: | August 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00447330 |
Health Authority: | United States: Food and Drug Administration |
metastatic esophagogastric adenocarcinomas ESOPHAGEAL CANCER GASTRIC CANCER ADENOCARCINOMA TARGTED THERAPY |
BEVACIZUMAB CAPECITBAINE OXALIPLATIN METASTATIC |
Capecitabine Digestive System Neoplasms Esophageal disorder Gastrointestinal Diseases Esophageal Neoplasms Stomach cancer Bevacizumab Carcinoma Oxaliplatin Digestive System Diseases |
Stomach Diseases Stomach Neoplasms Head and Neck Neoplasms Neoplasm Metastasis Gastrointestinal Neoplasms Esophageal Diseases Adenocarcinoma Esophageal neoplasm Neoplasms, Glandular and Epithelial |
Antimetabolites Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |