Clinical trial NCT00457691: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metastatic Colorectal Cancer
Keywords: colorectal neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-04-06
Enrollment: 768
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: First dose of study treatment up to 30 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Baseline up to 30 months
measure: Number of Participants With Overall Confirmed Objective Response
timeFrame: Day 28 of Cycle 1 up to 30 months
measure: Duration of Response (DR)
timeFrame: Day 28 of Cycle 1 up to 30 months
measure: Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Assessment Inventory of Gastrointestinal Symptoms (MDASI-GI) Symptom Intensity Score
timeFrame: Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until end of treatment (EOT)/withdrawal
measure: Change From Baseline in MDASI-GI Symptom Interference Score
timeFrame: Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal
measure: Change From Baseline in European Quality of Life (EuroQol) EQ-5D Self-Report Questionnaire
timeFrame: Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal
measure: Change From Baseline in EuroQol (EQ) Visual Analog Scale (VAS) (EQ-VAS)
timeFrame: Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal
Other outcomes:
Locations:
city: La Plata
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Santa Fe
country: Argentina
facility: Pfizer Investigational Site
city: Wollongong
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: East Bentleigh
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Frankston
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Fremantle
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
city: St. Poelten
country: Austria
facility: Pfizer Investigational Site
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Gent
country: Belgium
facility: Pfizer Investigational Site
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Liege
country: Belgium
facility: Pfizer Investigational Site
city: Sarajevo
country: Bosnia and Herzegovina
facility: Pfizer Investigational Site
city: Goiânia
country: Brazil
facility: Pfizer Investigational Site
state: GO
city: Curitiba
country: Brazil
facility: Pfizer Investigational Site
state: PR
city: Rio de Janeiro
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: Rio de Janeiro
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: Santo André
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Ruse
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Stara Zagora
country: Bulgaria
facility: Pfizer Investigational Site
city: Varna
country: Bulgaria
facility: Pfizer Investigational Site
city: Oshawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Santiago
country: Chile
facility: Pfizer Investigational Site
state: RM
city: Santiago
country: Chile
facility: Pfizer Investigational Site
state: RM
city: Medellin
country: Colombia
facility: Pfizer Investigational Site
state: Antioquia
city: Pasto
country: Colombia
facility: Pfizer Investigational Site
state: Narino
city: Nicosia
country: Cyprus
facility: Pfizer Investigational Site
city: Brno
country: Czech Republic
facility: Pfizer Investigational Site
city: Nova Ves Pod Plesi
country: Czech Republic
facility: Pfizer Investigational Site
city: Pribram
country: Czech Republic
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Bochum
country: Germany
facility: Pfizer Investigational Site
city: Esslingen
country: Germany
facility: Pfizer Investigational Site
city: Frankfurt
country: Germany
facility: Pfizer Investigational Site
city: Halle
country: Germany
facility: Pfizer Investigational Site
city: Hannover
country: Germany
facility: Pfizer Investigational Site
city: Moenchengladbach
country: Germany
facility: Pfizer Investigational Site
city: Oldenburg
country: Germany
facility: Pfizer Investigational Site
city: Regensburg
country: Germany
facility: Pfizer Investigational Site
city: Hong Kong
country: Hong Kong
facility: Pfizer Investigational Site
city: Kowloon
country: Hong Kong
facility: Pfizer Investigational Site
city: Tuen Mun, New Territories
country: Hong Kong
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Debrecen
country: Hungary
facility: Pfizer Investigational Site
city: Debrecen
country: Hungary
facility: Pfizer Investigational Site
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Mumbai
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Mumbai
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Pune
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Pune
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Vellore
country: India
facility: Pfizer Investigational Site
state: Tamil Nadu
city: Dublin 24
country: Ireland
facility: Pfizer Investigational Site
city: Dublin
country: Ireland
facility: Pfizer Investigational Site
city: Dublin
country: Ireland
facility: Pfizer Investigational Site
city: Galway
country: Ireland
facility: Pfizer Investigational Site
city: Goyang-si
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Incheon
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: DF
city: Acapulco
country: Mexico
facility: Pfizer Investigational Site
state: Guerrero
city: Ciudad Obregon
country: Mexico
facility: Pfizer Investigational Site
state: Sonora
city: Forde
country: Norway
facility: Pfizer Investigational Site
city: Tonsberg
country: Norway
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Porto
country: Portugal
facility: Pfizer Investigational Site
city: Porto
country: Portugal
facility: Pfizer Investigational Site
city: Santa Maria da Feira
country: Portugal
facility: Pfizer Investigational Site
city: Évora
country: Portugal
facility: Pfizer Investigational Site
city: Cluj-Napoca
country: Romania
facility: Pfizer Investigational Site
state: Cluj
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Belgrade
country: Serbia
facility: Pfizer Investigational Site
city: Sremska Kamenica
country: Serbia
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Observatory
country: South Africa
facility: Pfizer Investigational Site
city: Panorama
country: South Africa
facility: Pfizer Investigational Site
city: Parktown
country: South Africa
facility: Pfizer Investigational Site
city: Port Elizabeth
country: South Africa
facility: Pfizer Investigational Site
city: Sandton
country: South Africa
facility: Pfizer Investigational Site
city: Elche
country: Spain
facility: Pfizer Investigational Site
state: Alicante
city: Santander
country: Spain
facility: Pfizer Investigational Site
state: Cantabria
city: Mostoles
country: Spain
facility: Pfizer Investigational Site
state: Madrid
city: Alicante
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Zaragoza
country: Spain
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Uppsala
country: Sweden
facility: Pfizer Investigational Site
city: Changhua
country: Taiwan
facility: Pfizer Investigational Site
city: Chiayi County
country: Taiwan
facility: Pfizer Investigational Site
city: Kaohsiang Hsien
country: Taiwan
facility: Pfizer Investigational Site
city: Kaohsiung
country: Taiwan
facility: Pfizer Investigational Site
city: Kwei-Shan, Taoyuan
country: Taiwan
facility: Pfizer Investigational Site
city: Taichung
country: Taiwan
facility: Pfizer Investigational Site
city: Tainan
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Rachathevee
country: Thailand
facility: Pfizer Investigational Site
state: Bangkok
city: Muang
country: Thailand
facility: Pfizer Investigational Site
state: Chiang Mai
city: Muang
country: Thailand
facility: Pfizer Investigational Site
state: Khon Kaen
city: Bangkok
country: Thailand
facility: Pfizer Investigational Site
city: Cherkasy
country: Ukraine
facility: Pfizer Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: Pfizer Investigational Site
city: Kyiv
country: Ukraine
facility: Pfizer Investigational Site
city: Lviv
country: Ukraine
facility: Pfizer Investigational Site
city: Uzhgorod
country: Ukraine
facility: Pfizer Investigational Site
city: Northwood
country: United Kingdom
facility: Pfizer Investigational Site
state: Middlesex
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.