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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00143403
First Posted: September 2, 2005
Last Update Posted: September 28, 2010
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:
Pfizer
  Purpose
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.

Condition Intervention Phase
Colorectal Neoplasms Liver Neoplasms Drug: Irinotecan + 5 FU + folinic acid Drug: Folinic Acid + 5 FU Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Overall Survival Rates [ Time Frame: Median follow-up time (42 months) ]
    Probability of being alive was calculated in a yearly increment.


Enrollment: 321
Study Start Date: December 2001
Study Completion Date: September 2009
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 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.
  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): NCT00143403


  Show 66 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00143403     History of Changes
Other Study ID Numbers: CPT-GMA-301
A5961076
First Submitted: September 1, 2005
First Posted: September 2, 2005
Results First Submitted: February 26, 2009
Results First Posted: June 1, 2009
Last Update Posted: September 28, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Liver Diseases
Irinotecan
Fluorouracil
Leucovorin
Levoleucovorin
Folic Acid
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes