NCT00673673

FOLFOX With Bevacizumab in Metastatic or Unresectable Gastroesophageal and Gastric Cancer

Phase II Study of FOLFOX With Bevacizumab (Avastin(TM)) in Metastatic or Unresectable Gastroesophageal and Gastric Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II open-label study to determine the anti-tumor efficacy and tolerability of FOLFOX in combination with bevacizumab (Avastin(TM))in patients with metastatic or unresectable gastroesophageal and gastric adenocarcinoma. Our primary objective is to determine the time to progression in patients treated with FOLFOX in combination with bevacizumab.

Conditions

• Gastroesophageal Cancer
• Gastric Cancer

Interventions

Type	Name	Description
DRUG	FOLFOX	Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours
DRUG	bevacizumab	bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy

Timeline

• Start date: 2008-05-01
• Primary completion: 2013-05-01
• Completion: 2014-07-01
• First posted: 2008-05-07
• Last updated: 2015-02-04
• Results posted: 2014-07-14

Locations

2 sites across 1 country: United States