NCT01129310

First Line Study of Irinotecan, Capecitabine and Oxaliplatin in Metastatic Gastric or Gastroesophageal Cancer.

A Multicentre, Open-label Phase II Study of Irinotecan, Capecitabine(Xeloda), and Oxaliplatin (IXO) as First Line Treatment in Patients With Metastatic Gastric or Gastroesophageal (GEJ) Adenocarcinoma.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: AHS Cancer Control Alberta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators hypothesize IXO chemotherapy will have an improvement in response rate and acceptable toxicity for uncurable metastatic gastric cancer compared to historical controls.

Detailed description

This is a single arm, open-label, multicentre, phase II trial in which patients with metastatic gastric or GEJ adenocarcinoma will be treated with the combination of irinotecan, capecitabine, and oxaliplatin (IXO).Patients will receive the combination of irinotecan, capecitabine, and oxaliplatin at the recommended phase II dose and sequence determined by the completed phase I trial. Patients will be treated on study until disease progression, overwhelming toxicity, or consent withdrawal.

Conditions

• Gastrointestinal Neoplasm
• Gastric Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Irinotecan-Capecitabine-Oxaliplatin	Irinotecan-160mg/m2 IV infusion over 60-90 min on Day 1 Capecitabine-1900mg/m2 daily PO in divided doses (=950mg/m2 BID) on days 2-15 Oxaliplatin- 100mg/m2 IV infusion over 2 hours Day 1

Timeline

• Start date: 2010-07-01
• Primary completion: 2018-05-18
• Completion: 2018-05-18
• First posted: 2010-05-24
• Last updated: 2019-02-25

Locations

1 site across 1 country: Canada