Overview

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