Oxaliplatin, Capecitabine and Avastin for Metastatic Esophagogastric Adenocarcinoma

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT00447330
Phase
PHASE2
Status
Completed

Conditions

  • Esophageal Neoplasms
  • Neoplasm Metastasis
  • Stomach Neoplasms

Eligibility Criteria

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

Interventions

  • capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin) — DRUG
    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 1-14 of the three week cycle. Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 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 day 1 of a three week cycle following the administration of oxaliplatin.

Study Details

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.

Key Dates

First listed
Mar 14, 2007
Start date
Feb 28, 2007
Status verified
Jul 2014
Primary completion
Jan 31, 2014
Completion
Jul 31, 2014

Study Design

Enrollment
60 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1

Primary Outcome Measure

Median Progression-Free Survival (PFS) [ Time Frame: 5 years from study start date ]

Locations (2)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710-
University of Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157-0001-

Find similar trials in Durham, NC

By research site
Duke University Medical Center· Durham, NCUniversity of Wake Forest Baptist Medical Center· Winston-Salem, NC

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