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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00143403 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Multi-Centre Phase III Open Label Randomised 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. |
Estimated Enrollment: | 321 |
Study Start Date: | December 2001 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
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
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2: Active Comparator |
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
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | CPT-GMA-301, A5961076 |
Study First Received: | September 1, 2005 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00143403 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Liver Diseases Digestive System Neoplasms Gastrointestinal Diseases Irinotecan Colonic Diseases Liver neoplasms Leucovorin Intestinal Diseases |
Rectal Diseases Intestinal Neoplasms Liver Neoplasms Digestive System Diseases Fluorouracil Neoplasm Metastasis Gastrointestinal Neoplasms Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Vitamin B Complex Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Vitamins Micronutrients Antineoplastic Agents, Phytogenic |