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

Primary Purpose

Colorectal Neoplasms, Liver Neoplasms

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Irinotecan + 5 FU + folinic acid
Folinic Acid + 5 FU
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
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  • Pfizer Investigational Site
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  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival Rates
Probability of being alive was calculated in a yearly increment.

Full Information

First Posted
September 1, 2005
Last Updated
September 24, 2010
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00143403
Brief Title
Comparing Irinotecan and 5 FU/FA To 5-FU/FA After Resection Of Liver Metastases For Colorectal Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Liver Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
321 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Irinotecan + 5 FU + folinic acid
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Folinic Acid + 5 FU
Intervention Description
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 Measure Information:
Title
Disease Free Survival (DFS)
Description
time interval between the date of randomization and the earliest date of local, regional or distant relapse, or death due to cancer.
Time Frame
last tumor assessment date or cut-off date, whichever is earlier.
Secondary Outcome Measure Information:
Title
Overall Survival Rates
Description
Probability of being alive was calculated in a yearly increment.
Time Frame
Median follow-up time (42 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Herlev
ZIP/Postal Code
DK-2730
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Odense
ZIP/Postal Code
DK5000
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Amiens cedex 1
ZIP/Postal Code
80054
Country
France
Facility Name
Pfizer Investigational Site
City
Avignon
ZIP/Postal Code
84000
Country
France
Facility Name
Pfizer Investigational Site
City
Boulogne Billancourt cedex
Country
France
Facility Name
Pfizer Investigational Site
City
Clermont-Ferand Cedex 1
ZIP/Postal Code
63058
Country
France
Facility Name
Pfizer Investigational Site
City
Colmar
ZIP/Postal Code
68024
Country
France
Facility Name
Pfizer Investigational Site
City
Grenoble Cedex 09
ZIP/Postal Code
38043
Country
France
Facility Name
Pfizer Investigational Site
City
Marseille Cedex 9
ZIP/Postal Code
13273
Country
France
Facility Name
Pfizer Investigational Site
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Pfizer Investigational Site
City
Marseille
ZIP/Postal Code
13273 CEDEX 09
Country
France
Facility Name
Pfizer Investigational Site
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Pfizer Investigational Site
City
Montpellier
ZIP/Postal Code
34298 CEDEX 5
Country
France
Facility Name
Pfizer Investigational Site
City
Nice
ZIP/Postal Code
06031
Country
France
Facility Name
Pfizer Investigational Site
City
Nimes
ZIP/Postal Code
30900
Country
France
Facility Name
Pfizer Investigational Site
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Pfizer Investigational Site
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Pfizer Investigational Site
City
Toulouse cedex
ZIP/Postal Code
31059
Country
France
Facility Name
Pfizer Investigational Site
City
Cottbus
ZIP/Postal Code
03048
Country
Germany
Facility Name
Pfizer Investigational Site
City
Dessau
ZIP/Postal Code
06847
Country
Germany
Facility Name
Pfizer Investigational Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Pfizer Investigational Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Pfizer Investigational Site
City
Magdeburg
ZIP/Postal Code
39104
Country
Germany
Facility Name
Pfizer Investigational Site
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Pfizer Investigational Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Pfizer Investigational Site
City
Oldenburg
ZIP/Postal Code
26133
Country
Germany
Facility Name
Pfizer Investigational Site
City
Regensburg
ZIP/Postal Code
93042
Country
Germany
Facility Name
Pfizer Investigational Site
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hong Kong
Country
Hong Kong
Facility Name
Pfizer Investigational Site
City
Haifa
Country
Israel
Facility Name
Pfizer Investigational Site
City
Petach-Tikva
Country
Israel
Facility Name
Pfizer Investigational Site
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Pfizer Investigational Site
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Pfizer Investigational Site
City
Tel-Hashomer
Country
Israel
Facility Name
Pfizer Investigational Site
City
Carpi
State/Province
Modena
ZIP/Postal Code
41012
Country
Italy
Facility Name
Pfizer Investigational Site
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Pfizer Investigational Site
City
Latisana, UD
ZIP/Postal Code
33053
Country
Italy
Facility Name
Pfizer Investigational Site
City
Padova
ZIP/Postal Code
35100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Piacenza
ZIP/Postal Code
29100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Rozzano (Mi)
ZIP/Postal Code
20089
Country
Italy
Facility Name
Pfizer Investigational Site
City
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Goyang
ZIP/Postal Code
411764
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
120-753
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
139-240
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Porto
ZIP/Postal Code
4200
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Panorama
State/Province
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Pfizer Investigational Site
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Pfizer Investigational Site
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Pfizer Investigational Site
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Pfizer Investigational Site
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Taoyuan
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Donetsk
ZIP/Postal Code
83092
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kiev
ZIP/Postal Code
03922
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
N18 1QX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Surrey
ZIP/Postal Code
GU2 7XX
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=CPT-GMA-301&StudyName=Comparing%20Irinotecan%20and%205%20FU/FA%20To%205-FU/FA%20After%20Resection%20Of%20Liver%20Metastases%20For%20Colorectal%20Cancer
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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