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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00286000
First Posted: February 2, 2006
Last Update Posted: December 28, 2007
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:
University Hospital, Ghent
  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
Intervention Model: Single Group Assignment
Masking: None (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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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:
ClinicalTrials.gov Identifier: NCT00286000     History of Changes
Other Study ID Numbers: 2004/195
First Submitted: February 1, 2006
First Posted: February 2, 2006
Last Update Posted: December 28, 2007
Last Verified: December 2007

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