Status:
COMPLETED
Oxaliplatin, Capecitabine and Avastin for Metastatic Esophagogastric Adenocarcinoma
Lead Sponsor:
Duke University
Collaborating Sponsors:
Hoffmann-La Roche
Sanofi
Conditions:
Esophageal Neoplasms
Stomach Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 adenocarcinoma...
Detailed Description
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 a...
Eligibility Criteria
Inclusion
- Primary
- 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
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00447330
Start Date
February 1 2007
End Date
July 1 2014
Last Update
February 13 2015
Active Locations (2)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710
2
University of Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157-0001