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Irinotecan Discontinuation and Reintroduction for Advanced Colorectal Cancer

This study has been terminated.
(Poor accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00320320
First Posted: May 3, 2006
Last Update Posted: November 25, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Gachon University Gil Medical Center
  Purpose
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 Metastases Drug: Irinotecan Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00320320


Locations
Korea, Republic of
Gachon University Gil Medical Center
Incheon, Korea, Republic of, 405 760
Sponsors and Collaborators
Gachon University Gil Medical Center
Investigators
Principal Investigator: Se Hoon Park, MD Gachon University Gil Medical Center, Incheon, Korea
  More Information

ClinicalTrials.gov Identifier: NCT00320320     History of Changes
Other Study ID Numbers: GMO-GI-53
First Submitted: May 1, 2006
First Posted: May 3, 2006
Last Update Posted: November 25, 2008
Last Verified: November 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
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
Camptothecin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action