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

NCT00457691 | Completed Phase 3 Results DMC

• 1 other identifier: A6181122
• Study Type: interventional
• Target: 768
• Locations: 32 countries
• Sites: 126

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.

Conditions

Metastatic Colorectal Cancer

Keywords

colorectal neoplasms

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Overall Survival (OS)

  Baseline up to 30 months

• Number of Participants With Overall Confirmed Objective Response

  Day 28 of Cycle 1 up to 30 months

• Duration of Response (DR)

  Day 28 of Cycle 1 up to 30 months

• Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Assessment Inventory of Gastrointestinal Symptoms (MDASI-GI) Symptom Intensity Score

  Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until end of treatment (EOT)/withdrawal

• Change From Baseline in MDASI-GI Symptom Interference Score

  Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal

Study Arms (2)

1

EXPERIMENTAL

Drug: 5 fluorouracil; Drug: irinotecan; Drug: levo- leucovorin; Drug: sunitinib

2

PLACEBO COMPARATOR

Drug: 5 fluorouracil; Drug: irinotecan; Drug: levo- leucovorin; Drug: placebo

Interventions

5 fluorouracil DRUG

400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days

1

irinotecan DRUG

180mg/m2 iv day 1 every 14 days

1

levo- leucovorin DRUG

200mg/m2 iv; day 1 every 14 days

1

sunitinib DRUG

37.5mg of blinded therapy every day for 28 days followed by 14 days of blinded therapy free period

1

placebo DRUG

37.5mg of blinded placebo therapy every day for 28 days followed by 14 days of blinded therapy free period

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (132)

Pfizer Investigational Site

La Plata, Buenos Aires, B1902AVQ, Argentina

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Santa Fe, Santa Fe Province, S3000FFU, Argentina

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Wollongong, New South Wales, 2500, Australia

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East Bentleigh, Victoria, 3165, Australia

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Frankston, Victoria, 3199, Australia

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Fremantle, Western Australia, 6160, Australia

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Sankt Pölten, 3100, Austria

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Vienna, 1020, Austria

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Brussels, 1070, Belgium

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Brussels, 1200, Belgium

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Sarajevo, 71000, Bosnia and Herzegovina

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Goiânia, Goiás, 74075-040, Brazil

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Curitiba, Paraná, 80530-010, Brazil

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Rio de Janeiro, Rio de Janeiro, 20230-130, Brazil

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Rio de Janeiro, Rio de Janeiro, 20231 -050, Brazil

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Santo André, São Paulo, 09060-650, Brazil

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Sofia, Bulgaria, 1504, Bulgaria

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Rousse, 7002, Bulgaria

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Sofia, 1233, Bulgaria

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Sofia, 1756, Bulgaria

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Stara Zagora, 6003, Bulgaria

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Varna, 9000, Bulgaria

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Oshawa, Ontario, L1G 2B9, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Santiago, RM, 7510032, Chile

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Santiago, RM, Chile

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Medellín, Antioquia, 0, Colombia

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Pasto, Departamento de Nariño, 0, Colombia

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Nicosia, 2006, Cyprus

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Brno, 65653, Czechia

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Nová Ves pod Pleší, 26204, Czechia

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Příbram, 26105, Czechia

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Berlin, 12203, Germany

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Bochum, 44892, Germany

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Esslingen am Neckar, 73730, Germany

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Frankfurt, 60590, Germany

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Halle, 06120, Germany

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Hanover, 30625, Germany

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Mönchengladbach, 41063, Germany

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Oldenburg, 26133, Germany

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Regensburg, 93049, Germany

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Hong Kong, Hong Kong

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Kowloon, Hong Kong

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Tuen Mun, New Territories, 0, Hong Kong

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Budapest, 1106, Hungary

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Budapest, 1115, Hungary

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Budapest, 1122, Hungary

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Debrecen, 4032, Hungary

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Debrecen, 4043, Hungary

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Bangalore, Karnataka, 560 078, India

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Mumbai, Maharashtra, 400 012, India

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Mumbai, Maharashtra, 400026, India

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Pune, Maharashtra, 411 001, India

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Pune, Maharashtra, 411 016, India

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Vellore, Tamil Nadu, 632 004, India

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Dublin, 8, Ireland

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Dublin, 9, Ireland

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Dublin, Ireland

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Galway, Ireland

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Acapulco de Juárez, Guerrero, 39670, Mexico

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Mexico City, Mexico City, 14080, Mexico

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Ciudad Obregón, Sonora, 85000, Mexico

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Førde, 6807, Norway

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Tønsberg, 3103, Norway

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Warsaw, 00-909, Poland

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Warsaw, 02-097, Poland

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Warsaw, 02-781, Poland

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Evora, 7000-811, Portugal

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Porto, 4099-001, Portugal

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Porto, 4200-072, Portugal

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Santa Maria da Feira, 4520-211, Portugal

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Cluj-Napoca, Cluj, 400015, Romania

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Moscow, 115478, Russia

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Moscow, 123423, Russia

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Saint Petersburg, 191104, Russia

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Saint Petersburg, 195067, Russia

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Saint Petersburg, 197758, Russia

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Belgrade, Serbia, 11000, Serbia

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Kamenitz, Serbia, 21204, Serbia

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Belgrade, 11000, Serbia

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Kamenitz, 21204, Serbia

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Singapore, Singapore, 119074, Singapore

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Singapore, Singapore, 169610, Singapore

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Bratislava, 81250, Slovakia

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Bratislava, 833 10, Slovakia

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Observatory, 7925, South Africa

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Panorama, 7500, South Africa

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Parktown, 2193, South Africa

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Port Elizabeth, 6045, South Africa

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Sandton, 2199, South Africa

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Goyang-si, Gyeonggi-do, 410-769, South Korea

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Daegu, 700-712, South Korea

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Incheon, 405-760, South Korea

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Seoul, 110-744, South Korea

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Seoul, 120-752, South Korea

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Seoul, 135-710, South Korea

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Seoul, 138-736, South Korea

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Alicante, Alicante, 03010, Spain

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Elche, Alicante, 03202, Spain

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Barcelona, Barcelona, 08035, Spain

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Santander, Cantabria, 39008, Spain

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Madrid, Madrid, 28041, Spain

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Móstoles, Madrid, 28935, Spain

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Seville, Sevilla, 41013, Spain

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Zaragoza, Zaragoza, 50009, Spain

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Gothenburg, 416 85, Sweden

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Stockholm, 171 76, Sweden

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Uppsala, 751 85, Sweden

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Kaohsiang Hsien, Taiwan, 833, Taiwan

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Changhua, 500, Taiwan

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Chiayi County, 613, Taiwan

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Kaohsiung City, 813, Taiwan

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Kwei-Shan, Taoyuan, Taiwan

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Taichung, 40705, Taiwan

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Tainan, 736, Taiwan

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Taipei, 112, Taiwan

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Taipei, Taiwan

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Rachathevee, Bangkok, 10400, Thailand

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Muang, Changwat Khon Kaen, 40002, Thailand

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Muang, Chiang Mai, 50200, Thailand

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Bangkok, 10700, Thailand

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Cherkasy, 18009, Ukraine

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Dnipropetrovsk, 49102, Ukraine

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Kyiv, 03022, Ukraine

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Lviv, 79031, Ukraine

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Uzhhorod, 88014, Ukraine

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Northwood, Middlesex, HA6 2RN, United Kingdom

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London, NW1 2PQ, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Related Publications (1)

• 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.

  PMID: 23358972 DERIVED

Related Links

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

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Fluorouracil; Irinotecan; Leucovorin; Sunitinib

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Camptothecin; Alkaloids; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Pyrroles; Azoles; Indoles

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 4, 2007
• First Posted: April 6, 2007
• Study Start: June 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 30, 2015
• Results First Posted: June 3, 2011

Record last verified: 2015-03

Locations

SL (2); IE (4); AU (4); KR (7); TH (4); NO (2); PL (3); PT (4); AR (2); BE (5); RU (5); ME (3); ZA (5); HK (3); TW (9); CA (2); RO (1); CL (2); SE (3); BU (6); ES (8); BO (1); BR (5); CZ (3); CO (2); DE (9); UA (5); GB (3); CY (1); HU (5); IN (6); SG (2)