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

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. Identifier: NCT00143403
Recruitment Status : Completed
First Posted : September 2, 2005
Results First Posted : June 1, 2009
Last Update Posted : September 28, 2010
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Brief Summary:
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 or disease Intervention/treatment Phase
Colorectal Neoplasms Liver Neoplasms Drug: Irinotecan + 5 FU + folinic acid Drug: Folinic Acid + 5 FU Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 321 participants
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.
Study Start Date : December 2001
Actual Primary Completion Date : February 2008
Actual Study Completion Date : September 2009

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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

Primary Outcome Measures :
  1. 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 :
  1. Overall Survival Rates [ Time Frame: Median follow-up time (42 months) ]
    Probability of being alive was calculated in a yearly increment.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00143403

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Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

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

Additional relevant MeSH terms:
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
Folic Acid
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs