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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00457691




Registration number
NCT00457691
Ethics application status
Date submitted
4/04/2007
Date registered
6/04/2007
Date last updated
30/03/2015

Titles & IDs
Public title
Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer
Scientific 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
Secondary ID [1] 0 0
A6181122
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 5 fluorouracil
Treatment: Drugs - irinotecan
Treatment: Drugs - levo- leucovorin
Treatment: Drugs - sunitinib
Treatment: Drugs - 5 fluorouracil
Treatment: Drugs - irinotecan
Treatment: Drugs - levo- leucovorin
Treatment: Drugs - placebo

Experimental: 1 -

Placebo comparator: 2 -


Treatment: Drugs: 5 fluorouracil
400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days

Treatment: Drugs: irinotecan
180mg/m2 iv day 1 every 14 days

Treatment: Drugs: levo- leucovorin
200mg/m2 iv; day 1 every 14 days

Treatment: Drugs: sunitinib
37.5mg of blinded therapy every day for 28 days followed by 14 days of blinded therapy free period

Treatment: Drugs: 5 fluorouracil
400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days

Treatment: Drugs: irinotecan
180mg/m2 iv day 1 every 14 days

Treatment: Drugs: levo- leucovorin
200mg/m2 iv; day 1 every 14 days

Treatment: Drugs: placebo
37.5mg of blinded placebo therapy every day for 28 days followed by 14 days of blinded therapy free period
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
First dose of study treatment up to 30 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Baseline up to 30 months
Secondary outcome [2] 0 0
Number of Participants With Overall Confirmed Objective Response
Timepoint [2] 0 0
Day 28 of Cycle 1 up to 30 months
Secondary outcome [3] 0 0
Duration of Response (DR)
Timepoint [3] 0 0
Day 28 of Cycle 1 up to 30 months
Secondary outcome [4] 0 0
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Assessment Inventory of Gastrointestinal Symptoms (MDASI-GI) Symptom Intensity Score
Timepoint [4] 0 0
Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until end of treatment (EOT)/withdrawal
Secondary outcome [5] 0 0
Change From Baseline in MDASI-GI Symptom Interference Score
Timepoint [5] 0 0
Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal
Secondary outcome [6] 0 0
Change From Baseline in European Quality of Life (EuroQol) EQ-5D Self-Report Questionnaire
Timepoint [6] 0 0
Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal
Secondary outcome [7] 0 0
Change From Baseline in EuroQol (EQ) Visual Analog Scale (VAS) (EQ-VAS)
Timepoint [7] 0 0
Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2010
Sample size
Target
Accrual to date
Final
768
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Wollongong
Recruitment hospital [2] 0 0
Pfizer Investigational Site - East Bentleigh
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Frankston
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Fremantle
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
3165 - East Bentleigh
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment postcode(s) [4] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Santa Fe
Country [3] 0 0
Austria
State/province [3] 0 0
St. Poelten
Country [4] 0 0
Austria
State/province [4] 0 0
Wien
Country [5] 0 0
Belgium
State/province [5] 0 0
Bruxelles
Country [6] 0 0
Belgium
State/province [6] 0 0
Gent
Country [7] 0 0
Belgium
State/province [7] 0 0
Leuven
Country [8] 0 0
Belgium
State/province [8] 0 0
Liege
Country [9] 0 0
Bosnia and Herzegovina
State/province [9] 0 0
Sarajevo
Country [10] 0 0
Brazil
State/province [10] 0 0
GO
Country [11] 0 0
Brazil
State/province [11] 0 0
PR
Country [12] 0 0
Brazil
State/province [12] 0 0
RJ
Country [13] 0 0
Brazil
State/province [13] 0 0
SP
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Ruse
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Sofia
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Stara Zagora
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Varna
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Chile
State/province [19] 0 0
RM
Country [20] 0 0
Colombia
State/province [20] 0 0
Antioquia
Country [21] 0 0
Colombia
State/province [21] 0 0
Narino
Country [22] 0 0
Cyprus
State/province [22] 0 0
Nicosia
Country [23] 0 0
Czech Republic
State/province [23] 0 0
Brno
Country [24] 0 0
Czech Republic
State/province [24] 0 0
Nova Ves Pod Plesi
Country [25] 0 0
Czech Republic
State/province [25] 0 0
Pribram
Country [26] 0 0
Germany
State/province [26] 0 0
Berlin
Country [27] 0 0
Germany
State/province [27] 0 0
Bochum
Country [28] 0 0
Germany
State/province [28] 0 0
Esslingen
Country [29] 0 0
Germany
State/province [29] 0 0
Frankfurt
Country [30] 0 0
Germany
State/province [30] 0 0
Halle
Country [31] 0 0
Germany
State/province [31] 0 0
Hannover
Country [32] 0 0
Germany
State/province [32] 0 0
Moenchengladbach
Country [33] 0 0
Germany
State/province [33] 0 0
Oldenburg
Country [34] 0 0
Germany
State/province [34] 0 0
Regensburg
Country [35] 0 0
Hong Kong
State/province [35] 0 0
Hong Kong
Country [36] 0 0
Hong Kong
State/province [36] 0 0
Kowloon
Country [37] 0 0
Hong Kong
State/province [37] 0 0
Tuen Mun, New Territories
Country [38] 0 0
Hungary
State/province [38] 0 0
Budapest
Country [39] 0 0
Hungary
State/province [39] 0 0
Debrecen
Country [40] 0 0
India
State/province [40] 0 0
Karnataka
Country [41] 0 0
India
State/province [41] 0 0
Maharashtra
Country [42] 0 0
India
State/province [42] 0 0
Tamil Nadu
Country [43] 0 0
Ireland
State/province [43] 0 0
Dublin 24
Country [44] 0 0
Ireland
State/province [44] 0 0
Dublin
Country [45] 0 0
Ireland
State/province [45] 0 0
Galway
Country [46] 0 0
Korea, Republic of
State/province [46] 0 0
Gyeonggi-do
Country [47] 0 0
Korea, Republic of
State/province [47] 0 0
Daegu
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
Incheon
Country [49] 0 0
Korea, Republic of
State/province [49] 0 0
Seoul
Country [50] 0 0
Mexico
State/province [50] 0 0
DF
Country [51] 0 0
Mexico
State/province [51] 0 0
Guerrero
Country [52] 0 0
Mexico
State/province [52] 0 0
Sonora
Country [53] 0 0
Norway
State/province [53] 0 0
Forde
Country [54] 0 0
Norway
State/province [54] 0 0
Tonsberg
Country [55] 0 0
Poland
State/province [55] 0 0
Warszawa
Country [56] 0 0
Portugal
State/province [56] 0 0
Porto
Country [57] 0 0
Portugal
State/province [57] 0 0
Santa Maria da Feira
Country [58] 0 0
Portugal
State/province [58] 0 0
Évora
Country [59] 0 0
Romania
State/province [59] 0 0
Cluj
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Moscow
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Saint Petersburg
Country [62] 0 0
Russian Federation
State/province [62] 0 0
St. Petersburg
Country [63] 0 0
Serbia
State/province [63] 0 0
Belgrade
Country [64] 0 0
Serbia
State/province [64] 0 0
Sremska Kamenica
Country [65] 0 0
Singapore
State/province [65] 0 0
Singapore
Country [66] 0 0
Slovakia
State/province [66] 0 0
Bratislava
Country [67] 0 0
South Africa
State/province [67] 0 0
Observatory
Country [68] 0 0
South Africa
State/province [68] 0 0
Panorama
Country [69] 0 0
South Africa
State/province [69] 0 0
Parktown
Country [70] 0 0
South Africa
State/province [70] 0 0
Port Elizabeth
Country [71] 0 0
South Africa
State/province [71] 0 0
Sandton
Country [72] 0 0
Spain
State/province [72] 0 0
Alicante
Country [73] 0 0
Spain
State/province [73] 0 0
Cantabria
Country [74] 0 0
Spain
State/province [74] 0 0
Madrid
Country [75] 0 0
Spain
State/province [75] 0 0
Barcelona
Country [76] 0 0
Spain
State/province [76] 0 0
Sevilla
Country [77] 0 0
Spain
State/province [77] 0 0
Zaragoza
Country [78] 0 0
Sweden
State/province [78] 0 0
Goteborg
Country [79] 0 0
Sweden
State/province [79] 0 0
Stockholm
Country [80] 0 0
Sweden
State/province [80] 0 0
Uppsala
Country [81] 0 0
Taiwan
State/province [81] 0 0
Changhua
Country [82] 0 0
Taiwan
State/province [82] 0 0
Chiayi County
Country [83] 0 0
Taiwan
State/province [83] 0 0
Kaohsiang Hsien
Country [84] 0 0
Taiwan
State/province [84] 0 0
Kaohsiung
Country [85] 0 0
Taiwan
State/province [85] 0 0
Kwei-Shan, Taoyuan
Country [86] 0 0
Taiwan
State/province [86] 0 0
Taichung
Country [87] 0 0
Taiwan
State/province [87] 0 0
Tainan
Country [88] 0 0
Taiwan
State/province [88] 0 0
Taipei
Country [89] 0 0
Thailand
State/province [89] 0 0
Bangkok
Country [90] 0 0
Thailand
State/province [90] 0 0
Chiang Mai
Country [91] 0 0
Thailand
State/province [91] 0 0
Khon Kaen
Country [92] 0 0
Ukraine
State/province [92] 0 0
Cherkasy
Country [93] 0 0
Ukraine
State/province [93] 0 0
Dnipropetrovsk
Country [94] 0 0
Ukraine
State/province [94] 0 0
Kyiv
Country [95] 0 0
Ukraine
State/province [95] 0 0
Lviv
Country [96] 0 0
Ukraine
State/province [96] 0 0
Uzhgorod
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Middlesex
Country [98] 0 0
United Kingdom
State/province [98] 0 0
London
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00457691