FOLFOX With Bevacizumab in Metastatic or Unresectable Gastroesophageal and Gastric Cancer

Part of paid clinical trials in Hamden, Connecticut.

Sponsor
Yale University
Study ID
NCT00673673
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FOLFOX — DRUG
    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
  • bevacizumab — DRUG
    bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy

Study Details

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.

Key Dates

First listed
May 7, 2008
Start date
May 31, 2008
Status verified
Jan 2015
Primary completion
May 31, 2013
Completion
Jul 31, 2014

Study Design

Enrollment
39 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    FOLFOX in combination with bevacizumab

Primary Outcome Measure

Progression Free Survival [ Time Frame: Upon completion of study, up to 3 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Medical Oncology & Hematology PCHamdenConnecticut--
Yale University School of MedicineNew HavenConnecticut06520-

Find similar trials in Hamden, CT

By condition
Gastric cancer
By specialty
OncologyGI oncology
By research site
Medical Oncology & Hematology PC· Hamden, CTYale University School of Medicine· New Haven, CT

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