NCT00320320

Irinotecan Discontinuation and Reintroduction for Advanced Colorectal Cancer

A Pilot Phase II Trial of Irinotecan Discontinuation and Reintroduction in Patients With Previously Untreated Advanced Colorectal Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (planned)
• Sponsor: Gachon University Gil Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the feasibility and efficacy of first-line FOLFIRI discontinuation after initial 8 cycles and reintroduction after progression.

Detailed description

For medically-fit patients with advanced colorectal cancer, the current standard approach is chemotherapy with FOLFIRI or FOLFOX. Although a strategy of using sequential 5-FU, irinotecan and oxaliplatin has been thought to maximize overall survival in such patients, significant toxicity remains a problem. It has been suggested feasible that chemotherapy can be discontinued after 2-3 months and restart same treatment on progression in patients with chemosensitive colorectal cancer. Thus we designed this pilot phase II study to evaluate the feasibility and efficacy of first-line FOLFIRI discontinuation after initial 8 cycles and reintroduction after progression.

Conditions

• Colorectal Neoplasms
• Metastases

Interventions

Type	Name	Description
DRUG	Irinotecan

Timeline

• Start date: 2005-04-01
• Primary completion: 2007-04-01
• Completion: 2007-04-01
• First posted: 2006-05-03
• Last updated: 2008-11-25

Locations

1 site across 1 country: South Korea