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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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) - 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.
Timepoint [1] 0 0
First dose of study treatment up to 30 months
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline up to 30 months
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Day 28 of Cycle 1 up to 30 months
Secondary outcome [3] 0 0
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.
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 - 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).
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 - 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).
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 - 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.
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) - 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.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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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
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Cantabria
Country [74] 0 0
Spain
State/province [74] 0 0
Madrid
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Spain
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Barcelona
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Spain
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Sevilla
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Spain
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Zaragoza
Country [78] 0 0
Sweden
State/province [78] 0 0
Goteborg
Country [79] 0 0
Sweden
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Stockholm
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Sweden
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Uppsala
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Taiwan
State/province [81] 0 0
Changhua
Country [82] 0 0
Taiwan
State/province [82] 0 0
Chiayi County
Country [83] 0 0
Taiwan
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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
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.
Trial website
https://clinicaltrials.gov/show/NCT00457691
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

Summary results
Other publications