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Phase II Study of Oxaliplatin, Capecitabine, and Bevacizumab in the Treatment of Metastatic Esophagogastric Adenocarcinomas

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.

Eligibility

Primary Inclusion Criteria

To participate in this study, you must be 18 years or older and have:

  • 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 no prior therapy for metastatic disease
  • Prior radiation therapy is permitted, provided it is completed more than 28 days prior to day one of the study drug
  • Normal organ and marrow function
  • Karnofsky Performance Status 70-100 percent

Primary Exclusion Criteria

You will be excluded from the study if any of the following statements apply to you: 

  • Unstable or poorly controlled hypertension greater than 150/100 mm Hg
  • Arterial thromboembolic events within six months
  • Clinically significant uncontrolled cardiac disease
  • Excessive protein in the urine (proteinuria) at baseline
  • Grade two or greater peripheral neuropathy
  • History of abdominal fistula, GI perforation, or intra-abdominal abscess within six months 

Requirements

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 one through 14 of the three week cycle.

Oxaliplatin will be administered at the dose of 130 mg/m2 given as a two-hour intravenous infusion on the first day 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 the first day of a three week cycle following the administration of oxaliplatin.

For more information, contact the clinical research coordinator at 919-668-1861.


(REF# 8710)