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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00143403

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 III

MedlinePlus related topics: Cancer Colorectal Cancer Liver Cancer

Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Irinotecan Irinotecan hydrochloride Fluorouracil

U.S. FDA Resources

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.

Further study details as provided by Pfizer:

Primary Outcome Measures:

To improve the Disease Free Survival (DFS) 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. [ Time Frame: until progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare the safety profiles of the treatment groups [ Time Frame: 30 days after last dose of study medication ] [ Designated as safety issue: Yes ]
Overall survival [ Time Frame: until death ] [ Designated as safety issue: No ]

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
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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143403

Show 66 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

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

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 16, 2009