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

Colorectal Neoplasms Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00143403
• Other study ID #: CPT-GMA-301
• Secondary ID: A5961076
• Status: Completed
• Phase: Phase 3
• First received: September 1, 2005
• Last updated: September 24, 2010
• Start date: December 2001
• Est. completion date: September 2009

Study information

• Verified date: September 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: September 2009
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Liver Neoplasms
• Neoplasms

Intervention

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
• 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

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Gent
Belgium	Pfizer Investigational Site	Roeselare
Denmark	Pfizer Investigational Site	Copenhagen
Denmark	Pfizer Investigational Site	Herlev
Denmark	Pfizer Investigational Site	Odense
France	Pfizer Investigational Site	Amiens cedex 1
France	Pfizer Investigational Site	Avignon
France	Pfizer Investigational Site	Boulogne Billancourt cedex
France	Pfizer Investigational Site	Clermont-Ferand Cedex 1
France	Pfizer Investigational Site	Colmar
France	Pfizer Investigational Site	Grenoble Cedex 09
France	Pfizer Investigational Site	Marseille
France	Pfizer Investigational Site	Marseille
France	Pfizer Investigational Site	Marseille Cedex 9
France	Pfizer Investigational Site	Montpellier
France	Pfizer Investigational Site	Montpellier Cedex 5
France	Pfizer Investigational Site	Nice
France	Pfizer Investigational Site	Nimes
France	Pfizer Investigational Site	Rennes
France	Pfizer Investigational Site	Strasbourg
France	Pfizer Investigational Site	Toulouse cedex
Germany	Pfizer Investigational Site	Cottbus
Germany	Pfizer Investigational Site	Dessau
Germany	Pfizer Investigational Site	Erlangen
Germany	Pfizer Investigational Site	Hamburg
Germany	Pfizer Investigational Site	Leipzig
Germany	Pfizer Investigational Site	Magdeburg
Germany	Pfizer Investigational Site	Magdeburg
Germany	Pfizer Investigational Site	Mainz
Germany	Pfizer Investigational Site	Oldenburg
Germany	Pfizer Investigational Site	Regensburg
Germany	Pfizer Investigational Site	Tuebingen
Hong Kong	Pfizer Investigational Site	Hong Kong
Israel	Pfizer Investigational Site	Haifa
Israel	Pfizer Investigational Site	Petach-Tikva
Israel	Pfizer Investigational Site	Rehovot
Israel	Pfizer Investigational Site	Tel-Aviv
Israel	Pfizer Investigational Site	Tel-Hashomer
Italy	Pfizer Investigational Site	Brescia
Italy	Pfizer Investigational Site	Carpi	Modena
Italy	Pfizer Investigational Site	Latisana, UD
Italy	Pfizer Investigational Site	Padova
Italy	Pfizer Investigational Site	Parma
Italy	Pfizer Investigational Site	Piacenza
Italy	Pfizer Investigational Site	Reggio Emilia
Italy	Pfizer Investigational Site	Rozzano (Mi)
Korea, Republic of	Pfizer Investigational Site	Daegu
Korea, Republic of	Pfizer Investigational Site	Goyang
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Portugal	Pfizer Investigational Site	Porto
South Africa	Pfizer Investigational Site	Panorama	Cape Town
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	L'Hospitalet de Llobregat	Barcelona
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Santander	Cantabria
Spain	Pfizer Investigational Site	Sevilla
Sweden	Pfizer Investigational Site	Goteborg
Switzerland	Pfizer Investigational Site	Bern
Taiwan	Pfizer Investigational Site	Taoyuan
Ukraine	Pfizer Investigational Site	Donetsk
Ukraine	Pfizer Investigational Site	Kiev
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	Southampton
United Kingdom	Pfizer Investigational Site	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Belgium,  Denmark,  France,  Germany,  Hong Kong,  Israel,  Italy,  Korea, Republic of,  Portugal,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Overall Survival Rates	Probability of being alive was calculated in a yearly increment.	Median follow-up time (42 months)	No

External Links

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