Irinotecan Discontinuation and Reintroduction for Advanced Colorectal Cancer

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00320320
• Other study ID #: GMO-GI-53
• Status: Terminated
• Phase: Phase 2
• First received: May 1, 2006
• Last updated: November 24, 2008
• Start date: April 2005
• Est. completion date: April 2007

Study information

• Verified date: November 2008
• Source: Gachon University Gil Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 72
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastases

Intervention

Drug:
• Irinotecan

Locations

Country	Name	City	State
Korea, Republic of	Gachon University Gil Medical Center	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate after FOLFIRI reintroduction
Secondary	Progression-free survival
Secondary	Overall survival