Irinotecan Discontinuation and Reintroduction for Advanced Colorectal Cancer

• Status: Terminated
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gachon University Gil Medical Center
• Treatments: Camptothecin; Irinotecan

Criteria

Inclusion Criteria:

• Histologically proven adenocarcinoma of colon and rectum

• No prior chemotherapy or only adjuvant chemotherapy and/or radiotherapy

• Advanced, metastatic or recurrent not amenable to curative local therapy

• Measurable lesion(s)

• ECOG performance status 0 to 2

• Normal marrow, hepatic and renal function

• Provision of written informed consent

Exclusion Criteria:

• Active infection and/or severe comorbidity

• Known history of anaphylaxis of any origin