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Capecitabine and Oxaliplatin in Adenocarcinoma of the Small Bowel and Ampulla of Vater

NCT00354887 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2012-10-29

Study results available
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Summary

Primary Objective:

1\. To determine the objective response rate (complete plus partial) to the combination of capecitabine (Xeloda) and oxaliplatin (Eloxatin) (XELOX) in patients with adenocarcinoma of the small bowel and ampulla of Vater.

Secondary objectives include determining the toxicity, time-to-treatment failure, and overall survival rates in patients treated with this combination.

Conditions

Interventions

DRUG

Capecitabine

Oral capecitabine 750 mg/m\^2 twice daily (total daily dose 1500 mg/m\^2) on Days 1-14 in 21 Day Cycle.

DRUG

Oxaliplatin

130 mg/m\^2 by vein Day 1 over 2 hours in 21 Day Cycle

Sponsors & Collaborators

  • Sanofi-Synthelabo

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Robert A. Wolff, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00354887 on ClinicalTrials.gov