Comparing Irinotecan and 5 FU/FA To 5-FU/FA After Resection Of Liver Metastases For Colorectal Cancer

September 24, 2010 updated by: Pfizer

Multi-Centre Phase III Open Label Randomized Trial Comparing CPT-11 In Combination With A 5-FU/FA Infusional Regimen To The Same 5-FU/FA Infusional Regimen Alone, As Adjuvant Treatment After Resection Of Liver Metastases For Colorectal Cancer.

To see if Disease Free Survival (DFS) is improved when complete surgical resection of liver metastases (R0) is followed by chemotherapy with CPT-11 and 5-FU/FA as FOLFIRI regimen, compared to 5-FU/FA alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

321

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium, 9000
        • Pfizer Investigational Site
      • Roeselare, Belgium, 8800
        • Pfizer Investigational Site
  • Denmark
      • Copenhagen, Denmark, 2100
        • Pfizer Investigational Site
      • Herlev, Denmark, DK-2730
        • Pfizer Investigational Site
      • Odense, Denmark, DK5000
        • Pfizer Investigational Site
  • France
      • Amiens cedex 1, France, 80054
        • Pfizer Investigational Site
      • Avignon, France, 84000
        • Pfizer Investigational Site
      • Boulogne Billancourt cedex, France
        • Pfizer Investigational Site
      • Clermont-Ferand Cedex 1, France, 63058
        • Pfizer Investigational Site
      • Colmar, France, 68024
        • Pfizer Investigational Site
      • Grenoble Cedex 09, France, 38043
        • Pfizer Investigational Site
      • Marseille, France, 13005
        • Pfizer Investigational Site
      • Marseille, France, 13273 CEDEX 09
        • Pfizer Investigational Site
      • Marseille Cedex 9, France, 13273
        • Pfizer Investigational Site
      • Montpellier, France, 34298 CEDEX 5
        • Pfizer Investigational Site
      • Montpellier Cedex 5, France, 34295
        • Pfizer Investigational Site
      • Nice, France, 06031
        • Pfizer Investigational Site
      • Nimes, France, 30900
        • Pfizer Investigational Site
      • Rennes, France, 35042
        • Pfizer Investigational Site
      • Strasbourg, France, 67091
        • Pfizer Investigational Site
      • Toulouse cedex, France, 31059
        • Pfizer Investigational Site
  • Germany
      • Cottbus, Germany, 03048
        • Pfizer Investigational Site
      • Dessau, Germany, 06847
        • Pfizer Investigational Site
      • Erlangen, Germany, 91054
        • Pfizer Investigational Site
      • Hamburg, Germany, 20246
        • Pfizer Investigational Site
      • Leipzig, Germany, 04103
        • Pfizer Investigational Site
      • Magdeburg, Germany, 39104
        • Pfizer Investigational Site
      • Magdeburg, Germany, 39120
        • Pfizer Investigational Site
      • Mainz, Germany, 55131
        • Pfizer Investigational Site
      • Oldenburg, Germany, 26133
        • Pfizer Investigational Site
      • Regensburg, Germany, 93042
        • Pfizer Investigational Site
      • Tuebingen, Germany, 72076
        • Pfizer Investigational Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Pfizer Investigational Site
  • Israel
      • Haifa, Israel
        • Pfizer Investigational Site
      • Petach-Tikva, Israel
        • Pfizer Investigational Site
      • Rehovot, Israel, 76100
        • Pfizer Investigational Site
      • Tel-Aviv, Israel, 64239
        • Pfizer Investigational Site
      • Tel-Hashomer, Israel
        • Pfizer Investigational Site
  • Italy
      • Brescia, Italy, 25123
        • Pfizer Investigational Site
      • Latisana, UD, Italy, 33053
        • Pfizer Investigational Site
      • Padova, Italy, 35100
        • Pfizer Investigational Site
      • Parma, Italy, 43100
        • Pfizer Investigational Site
      • Piacenza, Italy, 29100
        • Pfizer Investigational Site
      • Reggio Emilia, Italy, 42100
        • Pfizer Investigational Site
      • Rozzano (Mi), Italy, 20089
        • Pfizer Investigational Site
    • Modena
      • Carpi, Modena, Italy, 41012
        • Pfizer Investigational Site
  • Korea, Republic of
      • Daegu, Korea, Republic of, 700-721
        • Pfizer Investigational Site
      • Goyang, Korea, Republic of, 411764
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 135-710
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 120-753
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 139-240
        • Pfizer Investigational Site
  • Portugal
      • Porto, Portugal, 4200
        • Pfizer Investigational Site
  • South Africa
    • Cape Town
      • Panorama, Cape Town, South Africa, 7500
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08036
        • Pfizer Investigational Site
      • Madrid, Spain, 28041
        • Pfizer Investigational Site
      • Sevilla, Spain, 41014
        • Pfizer Investigational Site
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Pfizer Investigational Site
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Pfizer Investigational Site
  • Sweden
      • Goteborg, Sweden, 413 45
        • Pfizer Investigational Site
  • Switzerland
      • Bern, Switzerland, 3010
        • Pfizer Investigational Site
  • Taiwan
      • Taoyuan, Taiwan
        • Pfizer Investigational Site
  • Ukraine
      • Donetsk, Ukraine, 83092
        • Pfizer Investigational Site
      • Kiev, Ukraine, 03922
        • Pfizer Investigational Site
  • United Kingdom
      • London, United Kingdom, N18 1QX
        • Pfizer Investigational Site
      • Southampton, United Kingdom, SO16 6YD
        • Pfizer Investigational Site
      • Surrey, United Kingdom, GU2 7XX
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically proven adenocarcinoma of the colon or rectum with complete resection of primary tumour.
  • Complete surgical resection (R0) of the liver metastasis(es) within a minimum of 3 weeks, and a maximum of 8 weeks prior to the first study treatment infusion.
  • Exclusively hepatic metastasis (es) : absence of bone, lung and brain metastases.

Exclusion Criteria:

  • Prior hepatic radiation or resection.
  • Prior radiofrequency ablation or cryoablation Incomplete surgical resection of liver metastasis (es).
  • Prior chemotherapy for metastatic disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Irinotecan + 5 FU + folinic acid
irinotecan 180 mg/m2 folinic acid 400 mg/m2 (DL) followed by 5 FU bolus 400 mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks
Active Comparator: 2
Drug: Folinic Acid + 5 FU
folinic acid 400 mg/m2(DL) followed by bolus 5 FU 400mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Free Survival (DFS)
Time Frame: last tumor assessment date or cut-off date, whichever is earlier.
time interval between the date of randomization and the earliest date of local, regional or distant relapse, or death due to cancer.
last tumor assessment date or cut-off date, whichever is earlier.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival Rates
Time Frame: Median follow-up time (42 months)
Probability of being alive was calculated in a yearly increment.
Median follow-up time (42 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (Estimate)

September 2, 2005

Study Record Updates

Last Update Posted (Estimate)

September 28, 2010

Last Update Submitted That Met QC Criteria

September 24, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPT-GMA-301
  • A5961076

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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