Oxaliplatin, Capecitabine and Avastin for Metastatic Esophagogastric Adenocarcinoma

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the progression free survival of capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin) in previously untreated metastatic esophagogastric adenocarcinomas.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborators: Genentech, Inc.; Hoffmann-La Roche; Sanofi
• Treatments: Bevacizumab; Capecitabine; Oxaliplatin

Criteria

Primary Inclusion Criteria:

• Histologically or cytologically documented and radiographically measurable adenocarcinoma of the esophagus or stomach that is metastatic/recurrent and not amenable to potentially curative treatment

• No prior therapy for metastatic disease

• Prior radiation therapy is permitted, provided it is completed > 28 days prior to day 1 of study drug

• Normal organ and marrow function

• Karnofsky Performance Status 70-100%

Primary Exclusion Criteria:

• Unstable or poorly controlled hypertension > 150/100 mm Hg

• Arterial thromboembolic events within 6 months

• Clinically significant uncontrolled cardiac disease

• Significant proteinuria at baseline

• Grade 2 or greater peripheral neuropathy

• History of abdominal fistula, GI perforation, or intra-abdominal abscess within 6 months