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

Phase 2 Completed 31 enrolled M.D. Anderson Cancer Center Sanofi-Synthelabo · collab

Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2004-11
Primary completion: 2009-11
Completion: 2009-11

Publications

Results Overman MJ, Varadhachary GR, Kopetz S, Adinin R, Lin E, Morris JS, Eng C, Abbruzzese JL, Wolff RA. Phase II study of capecitabine and oxaliplatin for advanced adenocarcinoma of the small bowel and ampulla of Vater. J Clin Oncol. 2009 Jun 1;27(16):2598-603. doi: 10.1200/JCO.2008.19.7145. Epub 2009 Jan 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capecitabine	Small molecule	750 mg/m2	Oral
Subject	Oxaliplatin	Small molecule	130 mg/m2	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications