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

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.

Study Overview

• Status: Terminated
• Conditions: Colorectal Neoplasms; Metastases
• Intervention / Treatment: Drug: Irinotecan

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.

• Study Type: Interventional
• Enrollment: 72
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of, 405 760
    • Gachon University Gil Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response rate after FOLFIRI reintroduction

Secondary Outcome Measures

Outcome Measure
Progression-free survival
Overall survival

Collaborators and Investigators

• Sponsor: Gachon University Gil Medical Center
• Investigators: Principal Investigator: Se Hoon Park, MD, Gachon University Gil Medical Center, Incheon, Korea

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Primary Completion (Actual): April 1, 2007
• Study Completion (Actual): April 1, 2007

Study Registration Dates

• First Submitted: May 1, 2006
• First Submitted That Met QC Criteria: May 1, 2006
• First Posted (Estimate): May 3, 2006

Study Record Updates

• Last Update Posted (Estimate): November 25, 2008
• Last Update Submitted That Met QC Criteria: November 24, 2008
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Keywords: No prior chemotherapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Irinotecan
• Other Study ID Numbers: GMO-GI-53