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High Dose Simplified Folfiri in Advanced Colorectal Cancer: a Multicentre Phase II Study

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00286000
First received: February 1, 2006
Last updated: December 19, 2007
Last verified: December 2007
History of Changes
  Purpose

A multicentre phase II study to evaluate the results of high dose simplified folfiri in advanced colorectal cancer


Condition Intervention Phase
Advanced Colorectal Cancer
 Drug: Administration of high dose simplified folfiri
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High Dose Simplified Folfiri in Advanced Colorectal Cancer: a Multicentre Phase II Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Response rate

Secondary Outcome Measures:
  • Resectability
  • Safety
  • TTP

Estimated Enrollment: 106
Study Start Date: June 2004
Study Completion Date: December 2005
  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically proven adenocarcinoma of the colon or rectum
  • Documented progressive metastatic disease
  • Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to response evaluation criteria in solid tumours (RECIST)
  • WHO performance status of 0 or 1
  • Adequate laboratory values of haematology, liverfunction and renal function
  • No previous chemotherapy for metastatic colorectal cancer

Exclusion Criteria:

  • Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except curatively treated cancer free of disease for more than 10 years.
  • Bowel obstruction or sub-obstruction. Crohn's disease, or ulcerative colitis.
  • Other severe illness or medical condition such as unstable cardiac disease under treatment, myocardial infarction within 6 months before inclusion.
  • Active uncontrolled infection
  • Other concomitant anticancer agent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00286000

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Marc Peeters, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
Website University Hospital Ghent  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00286000     History of Changes
Other Study ID Numbers: 2004/195
Study First Received: February 1, 2006
Last Updated: December 19, 2007
Health Authority: Belgium: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013