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Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer

Primary Purpose

Metastatic Colorectal Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
5 fluorouracil
irinotecan
levo- leucovorin
sunitinib
5 fluorouracil
irinotecan
levo- leucovorin
placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring colorectal neoplasms

Eligibility Criteria

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

Inclusion Criteria:

  • Confirmed (histologically or cytologically) colorectal adenocarcinoma with metastatic disease.
  • Not received previous therapy for metastatic colorectal disease but for whom FOLFIRI treatment is clinically indicated.
  • Adequate organ function defined by blood test.

Exclusion Criteria:

  • History of another primary cancer in the last 3 years.
  • Previous full field radiotherapy within the last 4 weeks or limited field radiotherapy within 2 weeks of enrolling into the study. Or previous radiation treatment of more that 30% of the bone marrow.
  • History of presence of brain metastasis, spinal cord compression carcinomatous meningitis or leptomeningeal disease.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS)
PFS defined as time from date of randomization to date of first documentation of objective tumour progression or death due to any cause, whichever occurred first.

Secondary Outcome Measures

Overall Survival (OS)
OS was defined as the time from randomization to the date of death due to any cause. OS data were censored on the day following the date of the last contact at which the patient was known to be alive.
Number of Participants With Overall Confirmed Objective Response
Objective disease response: participants with a confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Duration of Response (DR)
DR was defined as the time from the first objective documentation of CR or PR that was subsequently confirmed to the first documentation of disease progression or to death due to any cause, whichever occurred first.
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Assessment Inventory of Gastrointestinal Symptoms (MDASI-GI) Symptom Intensity Score
Symptom Intensity score is comprised of the sum of 13 MDASI core items (ie, pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, numbness or tingling). Participant asked to rate severity of each symptom at their worst in past 24 hours; each item rated from 0 to 10, with 0=symptom not present and 10=as bad as you can imagine; lower scores indicated better outcome (range: 0 to 130).
Change From Baseline in MDASI-GI Symptom Interference Score
Symptom Interference score is comprised of the sum 6 function items from MDASI core (general activity, walking, work, mood, relations with other people, and enjoyment of life). Participant asked to rate how much symptoms have interfered in past 24 hours; each item rated from 0 to 10, with 0=did not interfere and 10=interfered completely; lower scores indicated better outcome (range: 0 to 60).
Change From Baseline in European Quality of Life (EuroQol) EQ-5D Self-Report Questionnaire
EQ-5D: participant-rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problem); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain. Score is transformed and results in total score range -1.11 to 1.000; higher score indicates better health state.
Change From Baseline in EuroQol (EQ) Visual Analog Scale (VAS) (EQ-VAS)
EQ-5D: participant-rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.

Full Information

First Posted
April 4, 2007
Last Updated
March 10, 2015
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00457691
Brief Title
Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer
Official Title
A Multicenter, Randomised, Double-Blind, Phase 3 Study Of Sunitinib In Metastatic Colorectal Cancer Patients Receiving Irinotecan, 5-Fluorouracil And Leucovorin (FOLFIRI) As First Line Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to evaluate the safety and efficacy of FOLFIRI (Irinotecan, Leucovorin and 5 Fluorouracil) chemotherapy when combined with sunitinib or FOLFIRI chemotherapy without adding sunitinib as the first line treatment of patients with metastatic colorectal cancer.
Detailed Description
On June 25, 2009, the independent Data Monitoring Committee (DMC) reviewed the progress of Study A6181122. The DMC determined Study A6181122 had met pre-specified futility criteria and was unlikely to meet its primary endpoint to demonstrate a statistically significant improvement in progression-free survival (PFS) in patients treated with sunitinib plus FOLFIRI versus placebo plus FOLFIRI. No new safety findings were noted. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings. Patients receiving benefit on treatment as determined by the investigator may remain on study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
colorectal neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
768 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
5 fluorouracil
Intervention Description
400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days
Intervention Type
Drug
Intervention Name(s)
irinotecan
Intervention Description
180mg/m2 iv day 1 every 14 days
Intervention Type
Drug
Intervention Name(s)
levo- leucovorin
Intervention Description
200mg/m2 iv; day 1 every 14 days
Intervention Type
Drug
Intervention Name(s)
sunitinib
Intervention Description
37.5mg of blinded therapy every day for 28 days followed by 14 days of blinded therapy free period
Intervention Type
Drug
Intervention Name(s)
5 fluorouracil
Intervention Description
400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days
Intervention Type
Drug
Intervention Name(s)
irinotecan
Intervention Description
180mg/m2 iv day 1 every 14 days
Intervention Type
Drug
Intervention Name(s)
levo- leucovorin
Intervention Description
200mg/m2 iv; day 1 every 14 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
37.5mg of blinded placebo therapy every day for 28 days followed by 14 days of blinded therapy free period
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
PFS defined as time from date of randomization to date of first documentation of objective tumour progression or death due to any cause, whichever occurred first.
Time Frame
First dose of study treatment up to 30 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS was defined as the time from randomization to the date of death due to any cause. OS data were censored on the day following the date of the last contact at which the patient was known to be alive.
Time Frame
Baseline up to 30 months
Title
Number of Participants With Overall Confirmed Objective Response
Description
Objective disease response: participants with a confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Time Frame
Day 28 of Cycle 1 up to 30 months
Title
Duration of Response (DR)
Description
DR was defined as the time from the first objective documentation of CR or PR that was subsequently confirmed to the first documentation of disease progression or to death due to any cause, whichever occurred first.
Time Frame
Day 28 of Cycle 1 up to 30 months
Title
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Assessment Inventory of Gastrointestinal Symptoms (MDASI-GI) Symptom Intensity Score
Description
Symptom Intensity score is comprised of the sum of 13 MDASI core items (ie, pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, numbness or tingling). Participant asked to rate severity of each symptom at their worst in past 24 hours; each item rated from 0 to 10, with 0=symptom not present and 10=as bad as you can imagine; lower scores indicated better outcome (range: 0 to 130).
Time Frame
Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until end of treatment (EOT)/withdrawal
Title
Change From Baseline in MDASI-GI Symptom Interference Score
Description
Symptom Interference score is comprised of the sum 6 function items from MDASI core (general activity, walking, work, mood, relations with other people, and enjoyment of life). Participant asked to rate how much symptoms have interfered in past 24 hours; each item rated from 0 to 10, with 0=did not interfere and 10=interfered completely; lower scores indicated better outcome (range: 0 to 60).
Time Frame
Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal
Title
Change From Baseline in European Quality of Life (EuroQol) EQ-5D Self-Report Questionnaire
Description
EQ-5D: participant-rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problem); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain. Score is transformed and results in total score range -1.11 to 1.000; higher score indicates better health state.
Time Frame
Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal
Title
Change From Baseline in EuroQol (EQ) Visual Analog Scale (VAS) (EQ-VAS)
Description
EQ-5D: participant-rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.
Time Frame
Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed (histologically or cytologically) colorectal adenocarcinoma with metastatic disease. Not received previous therapy for metastatic colorectal disease but for whom FOLFIRI treatment is clinically indicated. Adequate organ function defined by blood test. Exclusion Criteria: History of another primary cancer in the last 3 years. Previous full field radiotherapy within the last 4 weeks or limited field radiotherapy within 2 weeks of enrolling into the study. Or previous radiation treatment of more that 30% of the bone marrow. History of presence of brain metastasis, spinal cord compression carcinomatous meningitis or leptomeningeal 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
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
B1902AVQ
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Santa Fe
ZIP/Postal Code
S3000FFU
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Pfizer Investigational Site
City
East Bentleigh
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
Facility Name
Pfizer Investigational Site
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Pfizer Investigational Site
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Pfizer Investigational Site
City
St. Poelten
ZIP/Postal Code
3100
Country
Austria
Facility Name
Pfizer Investigational Site
City
Wien
ZIP/Postal Code
1020
Country
Austria
Facility Name
Pfizer Investigational Site
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
Pfizer Investigational Site
City
Goiânia
State/Province
GO
ZIP/Postal Code
74075-040
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Curitiba
State/Province
PR
ZIP/Postal Code
80530-010
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20230-130
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20231 -050
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Santo André
State/Province
SP
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Sofia
ZIP/Postal Code
1504
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Stara Zagora
ZIP/Postal Code
6003
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Santiago
State/Province
RM
ZIP/Postal Code
7510032
Country
Chile
Facility Name
Pfizer Investigational Site
City
Santiago
State/Province
RM
Country
Chile
Facility Name
Pfizer Investigational Site
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
0
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Pasto
State/Province
Narino
ZIP/Postal Code
0
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Nicosia
ZIP/Postal Code
2006
Country
Cyprus
Facility Name
Pfizer Investigational Site
City
Brno
ZIP/Postal Code
65653
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Nova Ves Pod Plesi
ZIP/Postal Code
26204
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Pribram
ZIP/Postal Code
26105
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Pfizer Investigational Site
City
Bochum
ZIP/Postal Code
44892
Country
Germany
Facility Name
Pfizer Investigational Site
City
Esslingen
ZIP/Postal Code
73730
Country
Germany
Facility Name
Pfizer Investigational Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Pfizer Investigational Site
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Pfizer Investigational Site
City
Moenchengladbach
ZIP/Postal Code
41063
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
93049
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hong Kong
Country
Hong Kong
Facility Name
Pfizer Investigational Site
City
Kowloon
Country
Hong Kong
Facility Name
Pfizer Investigational Site
City
Tuen Mun, New Territories
ZIP/Postal Code
0
Country
Hong Kong
Facility Name
Pfizer Investigational Site
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Debrecen
ZIP/Postal Code
4043
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 078
Country
India
Facility Name
Pfizer Investigational Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400 012
Country
India
Facility Name
Pfizer Investigational Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400026
Country
India
Facility Name
Pfizer Investigational Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 001
Country
India
Facility Name
Pfizer Investigational Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 016
Country
India
Facility Name
Pfizer Investigational Site
City
Vellore
State/Province
Tamil Nadu
ZIP/Postal Code
632 004
Country
India
Facility Name
Pfizer Investigational Site
City
Dublin 24
Country
Ireland
Facility Name
Pfizer Investigational Site
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Facility Name
Pfizer Investigational Site
City
Dublin
ZIP/Postal Code
9
Country
Ireland
Facility Name
Pfizer Investigational Site
City
Galway
Country
Ireland
Facility Name
Pfizer Investigational Site
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
120-752
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
138-736
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Mexico
State/Province
DF
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Acapulco
State/Province
Guerrero
ZIP/Postal Code
39670
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Ciudad Obregon
State/Province
Sonora
ZIP/Postal Code
85000
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Forde
ZIP/Postal Code
6807
Country
Norway
Facility Name
Pfizer Investigational Site
City
Tonsberg
ZIP/Postal Code
3103
Country
Norway
Facility Name
Pfizer Investigational Site
City
Warszawa
ZIP/Postal Code
00-909
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Pfizer Investigational Site
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Santa Maria da Feira
ZIP/Postal Code
4520-211
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Évora
ZIP/Postal Code
7000-811
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400015
Country
Romania
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
123423
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Saint Petersburg
ZIP/Postal Code
191104
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Saint Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St. Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Pfizer Investigational Site
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
Pfizer Investigational Site
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Pfizer Investigational Site
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Pfizer Investigational Site
City
Bratislava
ZIP/Postal Code
81250
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Bratislava
ZIP/Postal Code
833 10
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Observatory
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Panorama
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Parktown
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Port Elizabeth
ZIP/Postal Code
6045
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Sandton
ZIP/Postal Code
2199
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Elche
State/Province
Alicante
ZIP/Postal Code
03202
Country
Spain
Facility Name
Pfizer Investigational Site
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Pfizer Investigational Site
City
Mostoles
State/Province
Madrid
ZIP/Postal Code
28935
Country
Spain
Facility Name
Pfizer Investigational Site
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08035
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
41013
Country
Spain
Facility Name
Pfizer Investigational Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Pfizer Investigational Site
City
Goteborg
ZIP/Postal Code
416 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Chiayi County
ZIP/Postal Code
613
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Kaohsiang Hsien
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Kwei-Shan, Taoyuan
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Tainan
ZIP/Postal Code
736
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Rachathevee
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Pfizer Investigational Site
City
Muang
State/Province
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Pfizer Investigational Site
City
Muang
State/Province
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Pfizer Investigational Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Pfizer Investigational Site
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kyiv
ZIP/Postal Code
03022
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Lviv
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Uzhgorod
ZIP/Postal Code
88014
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Northwood
State/Province
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
NW1 2PQ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23358972
Citation
Carrato A, Swieboda-Sadlej A, Staszewska-Skurczynska M, Lim R, Roman L, Shparyk Y, Bondarenko I, Jonker DJ, Sun Y, De la Cruz JA, Williams JA, Korytowsky B, Christensen JG, Lin X, Tursi JM, Lechuga MJ, Van Cutsem E. Fluorouracil, leucovorin, and irinotecan plus either sunitinib or placebo in metastatic colorectal cancer: a randomized, phase III trial. J Clin Oncol. 2013 Apr 1;31(10):1341-7. doi: 10.1200/JCO.2012.45.1930. Epub 2013 Jan 28.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181122&StudyName=Study%20Of%20FOLFIRI%20Chemotherapy%20With%20Or%20Without%20Sunitinib%20In%20Patients%20With%20Metastatic%20Colorectal%20Cancer%0A
Description
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Learn more about this trial

Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer

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