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Irinotecan Discontinuation and Reintroduction for Advanced Colorectal Cancer

This study has been terminated.
(Poor accrual)
Information provided by:
Gachon University Gil Medical Center Identifier:
First received: May 1, 2006
Last updated: November 24, 2008
Last verified: November 2008
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.

Condition Intervention Phase
Colorectal Neoplasms
Drug: Irinotecan
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Phase II Trial of Irinotecan Discontinuation and Reintroduction in Patients With Previously Untreated Advanced Colorectal Cancer

Resource links provided by NLM:

Further study details as provided by Gachon University Gil Medical Center:

Primary Outcome Measures:
  • Response rate after FOLFIRI reintroduction

Secondary Outcome Measures:
  • Progression-free survival
  • Overall survival

Estimated Enrollment: 72
Study Start Date: April 2005
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00320320

Korea, Republic of
Gachon University Gil Medical Center
Incheon, Korea, Republic of, 405 760
Sponsors and Collaborators
Gachon University Gil Medical Center
Principal Investigator: Se Hoon Park, MD Gachon University Gil Medical Center, Incheon, Korea
  More Information Identifier: NCT00320320     History of Changes
Other Study ID Numbers: GMO-GI-53
Study First Received: May 1, 2006
Last Updated: November 24, 2008

Keywords provided by Gachon University Gil Medical Center:
No prior chemotherapy

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017