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

NCT00143403 | Completed Phase 3 Results

• 2 other identifiers: CPT-GMA-301A5961076
• Study Type: interventional
• Target: 321
• Locations: 16 countries
• Sites: 66

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.

Conditions

Colorectal Neoplasms; Liver Neoplasms

Outcome Measures

Primary Outcomes (1)

• Disease Free Survival (DFS)

  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 Outcomes (1)

• Overall Survival Rates

  Median follow-up time (42 months)

Study Arms (2)

1

EXPERIMENTAL

Drug: Irinotecan + 5 FU + folinic acid

2

ACTIVE COMPARATOR

Drug: Folinic Acid + 5 FU

Interventions

Irinotecan + 5 FU + folinic acid DRUG

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

1

Folinic Acid + 5 FU DRUG

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

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (66)

Pfizer Investigational Site

Ghent, 9000, Belgium

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Roeselare, 8800, Belgium

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Copenhagen, 2100, Denmark

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Herlev, DK-2730, Denmark

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Odense, DK5000, Denmark

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Amiens, 80054, France

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Avignon, 84000, France

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Boulogne-Billancourt, France

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Clermont-Ferand Cedex 1, 63058, France

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Colmar, 68024, France

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Grenoble, 38043, France

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Marseille, 13005, France

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Marseille, 13273 CEDEX 09, France

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Marseille, 13273, France

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Montpellier, 34295, France

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Montpellier, 34298 CEDEX 5, France

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Nice, 06031, France

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Nîmes, 30900, France

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Rennes, 35042, France

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Strasbourg, 67091, France

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Toulouse, 31059, France

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Cottbus, 03048, Germany

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Dessau, 06847, Germany

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Erlangen, 91054, Germany

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Hamburg, 20246, Germany

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Leipzig, 04103, Germany

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Magdeburg, 39104, Germany

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Magdeburg, 39120, Germany

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Mainz, 55131, Germany

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Oldenburg, 26133, Germany

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Regensburg, 93042, Germany

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Tübingen, 72076, Germany

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Hong Kong, Hong Kong

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Haifa, Israel

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Petah Tikva, Israel

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Rehovot, 76100, Israel

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Tel Aviv, 64239, Israel

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Tel Litwinsky, Israel

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Carpi, Modena, 41012, Italy

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Brescia, 25123, Italy

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Latisana, UD, 33053, Italy

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Padua, 35100, Italy

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Parma, 43100, Italy

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Piacenza, 29100, Italy

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Reggio Emilia, 42100, Italy

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Rozzano (Mi), 20089, Italy

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Porto, 4200, Portugal

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Panorama, Cape Town, 7500, South Africa

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Daegu, 700-721, South Korea

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Goyang, 411764, South Korea

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Seoul, 120-753, South Korea

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Seoul, 135-710, South Korea

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Seoul, 139-240, South Korea

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Barcelona, Barcelona, 08036, Spain

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L'Hospitalet de Llobregat, Barcelona, 08907, Spain

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Santander, Cantabria, 39008, Spain

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Madrid, Madrid, 28041, Spain

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Seville, Sevilla, 41014, Spain

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Gothenburg, 413 45, Sweden

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Bern, 3010, Switzerland

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Taoyuan District, Taiwan

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Donetsk, Ukraine, 83092, Ukraine

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Kiev, 03922, Ukraine

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London, N18 1QX, United Kingdom

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Southampton, SO16 6YD, United Kingdom

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Pfizer Investigational Site

Surrey, GU2 7XX, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Colorectal Neoplasms; Liver Neoplasms

Interventions

Irinotecan; Fluorouracil; Leucovorin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 2, 2005
• Study Start: December 1, 2001
• Primary Completion: February 1, 2008
• Study Completion: September 1, 2009
• Last Updated: September 28, 2010
• Results First Posted: June 1, 2009

Record last verified: 2010-09

Locations

ES (5); ZA (1); CH (1); GB (3); IL (5); FR (16); SE (1); BE (2); IT (8); PT (1); DE (11); KR (5); TW (1); DK (3); HK (1); UA (2)