CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 31 enrolled
Drug / intervention
Capecitabine +1 moredrug
Likely dose
Capecitabine 750 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00354887
NCT00354887Phase 2Completed
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A Phase II Study of Capecitabine and Oxaliplatin (XELOX) in Adenocarcinoma of the Small Bowel and Ampulla of Vater

M.D. Anderson Cancer Center·interventional·Posted Jul 20, 2006·Updated Oct 29, 2012

In Brief

A Phase 2 clinical trial evaluating Capecitabine and Oxaliplatin for Gastrointestinal Cancer. Completed, enrolled 31 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastrointestinal Cancer
CountriesUnited States
CollaboratorsSanofi-Synthelabo

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 20, 2006
Enrollment StartNov 1, 2004
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 19.9 years ago

Interventions

Capecitabinedrug

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

Oxaliplatindrug

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