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

Metastatic Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00457691
• Other study ID #: A6181122
• Status: Completed
• Phase: Phase 3
• First received: April 4, 2007
• Last updated: March 10, 2015
• Start date: June 2007
• Est. completion date: March 2010

Study information

• Verified date: March 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 768
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• 5 fluorouracil
400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days
• irinotecan
180mg/m2 iv day 1 every 14 days
• levo- leucovorin
200mg/m2 iv; day 1 every 14 days
• sunitinib
37.5mg of blinded therapy every day for 28 days followed by 14 days of blinded therapy free period
• 5 fluorouracil
400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days
• irinotecan
180mg/m2 iv day 1 every 14 days
• levo- leucovorin
200mg/m2 iv; day 1 every 14 days
• placebo
37.5mg of blinded placebo therapy every day for 28 days followed by 14 days of blinded therapy free period

Locations

Country	Name	City	State
Argentina	Pfizer Investigational Site	La Plata	Buenos Aires
Argentina	Pfizer Investigational Site	Santa Fe
Australia	Pfizer Investigational Site	East Bentleigh	Victoria
Australia	Pfizer Investigational Site	Frankston	Victoria
Australia	Pfizer Investigational Site	Fremantle	Western Australia
Australia	Pfizer Investigational Site	Wollongong	New South Wales
Austria	Pfizer Investigational Site	St. Poelten
Austria	Pfizer Investigational Site	Wien
Belgium	Pfizer Investigational Site	Bruxelles
Belgium	Pfizer Investigational Site	Bruxelles
Belgium	Pfizer Investigational Site	Gent
Belgium	Pfizer Investigational Site	Leuven
Belgium	Pfizer Investigational Site	Liege
Bosnia and Herzegovina	Pfizer Investigational Site	Sarajevo
Brazil	Pfizer Investigational Site	Curitiba	PR
Brazil	Pfizer Investigational Site	Goiânia	GO
Brazil	Pfizer Investigational Site	Rio de Janeiro	RJ
Brazil	Pfizer Investigational Site	Rio de Janeiro	RJ
Brazil	Pfizer Investigational Site	Santo André	SP
Bulgaria	Pfizer Investigational Site	Ruse
Bulgaria	Pfizer Investigational Site	Sofia
Bulgaria	Pfizer Investigational Site	Sofia
Bulgaria	Pfizer Investigational Site	Sofia
Bulgaria	Pfizer Investigational Site	Stara Zagora
Bulgaria	Pfizer Investigational Site	Varna
Canada	Pfizer Investigational Site	Oshawa	Ontario
Canada	Pfizer Investigational Site	Ottawa	Ontario
Chile	Pfizer Investigational Site	Santiago	RM
Chile	Pfizer Investigational Site	Santiago	RM
Colombia	Pfizer Investigational Site	Medellin	Antioquia
Colombia	Pfizer Investigational Site	Pasto	Narino
Cyprus	Pfizer Investigational Site	Nicosia
Czech Republic	Pfizer Investigational Site	Brno
Czech Republic	Pfizer Investigational Site	Nova Ves Pod Plesi
Czech Republic	Pfizer Investigational Site	Pribram
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Bochum
Germany	Pfizer Investigational Site	Esslingen
Germany	Pfizer Investigational Site	Frankfurt
Germany	Pfizer Investigational Site	Halle
Germany	Pfizer Investigational Site	Hannover
Germany	Pfizer Investigational Site	Moenchengladbach
Germany	Pfizer Investigational Site	Oldenburg
Germany	Pfizer Investigational Site	Regensburg
Hong Kong	Pfizer Investigational Site	Hong Kong
Hong Kong	Pfizer Investigational Site	Kowloon
Hong Kong	Pfizer Investigational Site	Tuen Mun, New Territories
Hungary	Pfizer Investigational Site	Budapest
Hungary	Pfizer Investigational Site	Budapest
Hungary	Pfizer Investigational Site	Budapest
Hungary	Pfizer Investigational Site	Debrecen
Hungary	Pfizer Investigational Site	Debrecen
India	Pfizer Investigational Site	Bangalore	Karnataka
India	Pfizer Investigational Site	Mumbai	Maharashtra
India	Pfizer Investigational Site	Mumbai	Maharashtra
India	Pfizer Investigational Site	Pune	Maharashtra
India	Pfizer Investigational Site	Pune	Maharashtra
India	Pfizer Investigational Site	Vellore	Tamil Nadu
Ireland	Pfizer Investigational Site	Dublin
Ireland	Pfizer Investigational Site	Dublin
Ireland	Pfizer Investigational Site	Dublin 24
Ireland	Pfizer Investigational Site	Galway
Korea, Republic of	Pfizer Investigational Site	Daegu
Korea, Republic of	Pfizer Investigational Site	Goyang-si	Gyeonggi-do
Korea, Republic of	Pfizer Investigational Site	Incheon
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Mexico	Pfizer Investigational Site	Acapulco	Guerrero
Mexico	Pfizer Investigational Site	Ciudad Obregon	Sonora
Mexico	Pfizer Investigational Site	Mexico	DF
Norway	Pfizer Investigational Site	Forde
Norway	Pfizer Investigational Site	Tonsberg
Poland	Pfizer Investigational Site	Warszawa
Poland	Pfizer Investigational Site	Warszawa
Poland	Pfizer Investigational Site	Warszawa
Portugal	Pfizer Investigational Site	Évora
Portugal	Pfizer Investigational Site	Porto
Portugal	Pfizer Investigational Site	Porto
Portugal	Pfizer Investigational Site	Santa Maria da Feira
Romania	Pfizer Investigational Site	Cluj-Napoca	Cluj
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Saint Petersburg
Russian Federation	Pfizer Investigational Site	Saint Petersburg
Russian Federation	Pfizer Investigational Site	St. Petersburg
Serbia	Pfizer Investigational Site	Belgrade
Serbia	Pfizer Investigational Site	Sremska Kamenica
Singapore	Pfizer Investigational Site	Singapore
Singapore	Pfizer Investigational Site	Singapore
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Bratislava
South Africa	Pfizer Investigational Site	Observatory
South Africa	Pfizer Investigational Site	Panorama
South Africa	Pfizer Investigational Site	Parktown
South Africa	Pfizer Investigational Site	Port Elizabeth
South Africa	Pfizer Investigational Site	Sandton
Spain	Pfizer Investigational Site	Alicante
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Elche	Alicante
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Mostoles	Madrid
Spain	Pfizer Investigational Site	Santander	Cantabria
Spain	Pfizer Investigational Site	Sevilla
Spain	Pfizer Investigational Site	Zaragoza
Sweden	Pfizer Investigational Site	Goteborg
Sweden	Pfizer Investigational Site	Stockholm
Sweden	Pfizer Investigational Site	Uppsala
Taiwan	Pfizer Investigational Site	Changhua
Taiwan	Pfizer Investigational Site	Chiayi County
Taiwan	Pfizer Investigational Site	Kaohsiang Hsien
Taiwan	Pfizer Investigational Site	Kaohsiung
Taiwan	Pfizer Investigational Site	Kwei-Shan, Taoyuan
Taiwan	Pfizer Investigational Site	Taichung
Taiwan	Pfizer Investigational Site	Tainan
Taiwan	Pfizer Investigational Site	Taipei
Taiwan	Pfizer Investigational Site	Taipei
Thailand	Pfizer Investigational Site	Bangkok
Thailand	Pfizer Investigational Site	Muang	Chiang Mai
Thailand	Pfizer Investigational Site	Muang	Khon Kaen
Thailand	Pfizer Investigational Site	Rachathevee	Bangkok
Ukraine	Pfizer Investigational Site	Cherkasy
Ukraine	Pfizer Investigational Site	Dnipropetrovsk
Ukraine	Pfizer Investigational Site	Kyiv
Ukraine	Pfizer Investigational Site	Lviv
Ukraine	Pfizer Investigational Site	Uzhgorod
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	Manchester
United Kingdom	Pfizer Investigational Site	Northwood	Middlesex

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Argentina,  Australia,  Austria,  Belgium,  Bosnia and Herzegovina,  Brazil,  Bulgaria,  Canada,  Chile,  Colombia,  Cyprus,  Czech Republic,  Germany,  Hong Kong,  Hungary,  India,  Ireland,  Korea, Republic of,  Mexico,  Norway,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Singapore,  Slovakia,  South Africa,  Spain,  Sweden,  Taiwan,  Thailand,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	First dose of study treatment up to 30 months	No
Secondary	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.	Baseline up to 30 months	No
Secondary	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.	Day 28 of Cycle 1 up to 30 months	No
Secondary	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.	Day 28 of Cycle 1 up to 30 months	No
Secondary	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).	Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until end of treatment (EOT)/withdrawal	No
Secondary	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).	Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal	No
Secondary	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.	Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal	No
Secondary	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.	Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal	No

External Links

•   To obtain contact information for a study center near you, click here.