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

March 10, 2015 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

768

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Santa Fe, Argentina, S3000FFU
        • Pfizer Investigational Site
    • Buenos Aires
      • La Plata, Buenos Aires, Argentina, B1902AVQ
        • Pfizer Investigational Site
  • Australia
    • New South Wales
      • Wollongong, New South Wales, Australia, 2500
        • Pfizer Investigational Site
    • Victoria
      • East Bentleigh, Victoria, Australia, 3165
        • Pfizer Investigational Site
      • Frankston, Victoria, Australia, 3199
        • Pfizer Investigational Site
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Pfizer Investigational Site
  • Austria
      • St. Poelten, Austria, 3100
        • Pfizer Investigational Site
      • Wien, Austria, 1020
        • Pfizer Investigational Site
  • Belgium
      • Bruxelles, Belgium, 1070
        • Pfizer Investigational Site
      • Bruxelles, Belgium, 1200
        • Pfizer Investigational Site
      • Gent, Belgium, 9000
        • Pfizer Investigational Site
      • Leuven, Belgium, 3000
        • Pfizer Investigational Site
      • Liege, Belgium, 4000
        • Pfizer Investigational Site
  • Bosnia and Herzegovina
      • Sarajevo, Bosnia and Herzegovina, 71000
        • Pfizer Investigational Site
  • Brazil
    • GO
      • Goiânia, GO, Brazil, 74075-040
        • Pfizer Investigational Site
    • PR
      • Curitiba, PR, Brazil, 80530-010
        • Pfizer Investigational Site
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20230-130
        • Pfizer Investigational Site
      • Rio de Janeiro, RJ, Brazil, 20231 -050
        • Pfizer Investigational Site
    • SP
      • Santo André, SP, Brazil, 09060-650
        • Pfizer Investigational Site
  • Bulgaria
      • Ruse, Bulgaria, 7002
        • Pfizer Investigational Site
      • Sofia, Bulgaria, 1233
        • Pfizer Investigational Site
      • Sofia, Bulgaria, 1756
        • Pfizer Investigational Site
      • Sofia, Bulgaria, 1504
        • Pfizer Investigational Site
      • Stara Zagora, Bulgaria, 6003
        • Pfizer Investigational Site
      • Varna, Bulgaria, 9000
        • Pfizer Investigational Site
  • Canada
    • Ontario
      • Oshawa, Ontario, Canada, L1G 2B9
        • Pfizer Investigational Site
      • Ottawa, Ontario, Canada, K1H 8L6
        • Pfizer Investigational Site
  • Chile
    • RM
      • Santiago, RM, Chile, 7510032
        • Pfizer Investigational Site
      • Santiago, RM, Chile
        • Pfizer Investigational Site
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
        • Pfizer Investigational Site
    • Narino
      • Pasto, Narino, Colombia
        • Pfizer Investigational Site
  • Cyprus
      • Nicosia, Cyprus, 2006
        • Pfizer Investigational Site
  • Czech Republic
      • Brno, Czech Republic, 65653
        • Pfizer Investigational Site
      • Nova Ves Pod Plesi, Czech Republic, 26204
        • Pfizer Investigational Site
      • Pribram, Czech Republic, 26105
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany, 12203
        • Pfizer Investigational Site
      • Bochum, Germany, 44892
        • Pfizer Investigational Site
      • Esslingen, Germany, 73730
        • Pfizer Investigational Site
      • Frankfurt, Germany, 60590
        • Pfizer Investigational Site
      • Halle, Germany, 06120
        • Pfizer Investigational Site
      • Hannover, Germany, 30625
        • Pfizer Investigational Site
      • Moenchengladbach, Germany, 41063
        • Pfizer Investigational Site
      • Oldenburg, Germany, 26133
        • Pfizer Investigational Site
      • Regensburg, Germany, 93049
        • Pfizer Investigational Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Pfizer Investigational Site
      • Kowloon, Hong Kong
        • Pfizer Investigational Site
      • Tuen Mun, New Territories, Hong Kong
        • Pfizer Investigational Site
  • Hungary
      • Budapest, Hungary, 1122
        • Pfizer Investigational Site
      • Budapest, Hungary, 1106
        • Pfizer Investigational Site
      • Budapest, Hungary, 1115
        • Pfizer Investigational Site
      • Debrecen, Hungary, 4043
        • Pfizer Investigational Site
      • Debrecen, Hungary, 4032
        • Pfizer Investigational Site
  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560 078
        • Pfizer Investigational Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400 012
        • Pfizer Investigational Site
      • Mumbai, Maharashtra, India, 400026
        • Pfizer Investigational Site
      • Pune, Maharashtra, India, 411 001
        • Pfizer Investigational Site
      • Pune, Maharashtra, India, 411 016
        • Pfizer Investigational Site
    • Tamil Nadu
      • Vellore, Tamil Nadu, India, 632 004
        • Pfizer Investigational Site
  • Ireland
      • Dublin, Ireland, 8
        • Pfizer Investigational Site
      • Dublin, Ireland, 9
        • Pfizer Investigational Site
      • Dublin 24, Ireland
        • Pfizer Investigational Site
      • Galway, Ireland
        • Pfizer Investigational Site
  • Korea, Republic of
      • Daegu, Korea, Republic of, 700-712
        • Pfizer Investigational Site
      • Incheon, Korea, Republic of, 405-760
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 120-752
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 138-736
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 110-744
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 135-710
        • Pfizer Investigational Site
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
        • Pfizer Investigational Site
  • Mexico
    • DF
      • Mexico, DF, Mexico, 14080
        • Pfizer Investigational Site
    • Guerrero
      • Acapulco, Guerrero, Mexico, 39670
        • Pfizer Investigational Site
    • Sonora
      • Ciudad Obregon, Sonora, Mexico, 85000
        • Pfizer Investigational Site
  • Norway
      • Forde, Norway, 6807
        • Pfizer Investigational Site
      • Tonsberg, Norway, 3103
        • Pfizer Investigational Site
  • Poland
      • Warszawa, Poland, 02-781
        • Pfizer Investigational Site
      • Warszawa, Poland, 02-097
        • Pfizer Investigational Site
      • Warszawa, Poland, 00-909
        • Pfizer Investigational Site
  • Portugal
      • Porto, Portugal, 4200-072
        • Pfizer Investigational Site
      • Porto, Portugal, 4099-001
        • Pfizer Investigational Site
      • Santa Maria da Feira, Portugal, 4520-211
        • Pfizer Investigational Site
      • Évora, Portugal, 7000-811
        • Pfizer Investigational Site
  • Romania
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Pfizer Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 123423
        • Pfizer Investigational Site
      • Saint Petersburg, Russian Federation, 195067
        • Pfizer Investigational Site
      • Saint Petersburg, Russian Federation, 191104
        • Pfizer Investigational Site
      • St. Petersburg, Russian Federation, 197758
        • Pfizer Investigational Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Pfizer Investigational Site
      • Sremska Kamenica, Serbia, 21204
        • Pfizer Investigational Site
  • Singapore
      • Singapore, Singapore, 119074
        • Pfizer Investigational Site
      • Singapore, Singapore, 169610
        • Pfizer Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 833 10
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 81250
        • Pfizer Investigational Site
  • South Africa
      • Observatory, South Africa, 7925
        • Pfizer Investigational Site
      • Panorama, South Africa, 7500
        • Pfizer Investigational Site
      • Parktown, South Africa, 2193
        • Pfizer Investigational Site
      • Port Elizabeth, South Africa, 6045
        • Pfizer Investigational Site
      • Sandton, South Africa, 2199
        • Pfizer Investigational Site
  • Spain
      • Alicante, Spain, 03010
        • Pfizer Investigational Site
      • Barcelona, Spain, 08035
        • Pfizer Investigational Site
      • Madrid, Spain, 28041
        • Pfizer Investigational Site
      • Sevilla, Spain, 41013
        • Pfizer Investigational Site
      • Zaragoza, Spain, 50009
        • Pfizer Investigational Site
    • Alicante
      • Elche, Alicante, Spain, 03202
        • Pfizer Investigational Site
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Pfizer Investigational Site
    • Madrid
      • Mostoles, Madrid, Spain, 28935
        • Pfizer Investigational Site
  • Sweden
      • Goteborg, Sweden, 416 85
        • Pfizer Investigational Site
      • Stockholm, Sweden, 171 76
        • Pfizer Investigational Site
      • Uppsala, Sweden, 751 85
        • Pfizer Investigational Site
  • Taiwan
      • Changhua, Taiwan, 500
        • Pfizer Investigational Site
      • Chiayi County, Taiwan, 613
        • Pfizer Investigational Site
      • Kaohsiang Hsien, Taiwan, 833
        • Pfizer Investigational Site
      • Kaohsiung, Taiwan, 813
        • Pfizer Investigational Site
      • Kwei-Shan, Taoyuan, Taiwan
        • Pfizer Investigational Site
      • Taichung, Taiwan, 40705
        • Pfizer Investigational Site
      • Tainan, Taiwan, 736
        • Pfizer Investigational Site
      • Taipei, Taiwan, 112
        • Pfizer Investigational Site
      • Taipei, Taiwan
        • Pfizer Investigational Site
  • Thailand
      • Bangkok, Thailand, 10700
        • Pfizer Investigational Site
    • Bangkok
      • Rachathevee, Bangkok, Thailand, 10400
        • Pfizer Investigational Site
    • Chiang Mai
      • Muang, Chiang Mai, Thailand, 50200
        • Pfizer Investigational Site
    • Khon Kaen
      • Muang, Khon Kaen, Thailand, 40002
        • Pfizer Investigational Site
  • Ukraine
      • Cherkasy, Ukraine, 18009
        • Pfizer Investigational Site
      • Dnipropetrovsk, Ukraine, 49102
        • Pfizer Investigational Site
      • Kyiv, Ukraine, 03022
        • Pfizer Investigational Site
      • Lviv, Ukraine, 79031
        • Pfizer Investigational Site
      • Uzhgorod, Ukraine, 88014
        • Pfizer Investigational Site
  • United Kingdom
      • London, United Kingdom, NW1 2PQ
        • Pfizer Investigational Site
      • Manchester, United Kingdom, M20 4BX
        • Pfizer Investigational Site
    • Middlesex
      • Northwood, Middlesex, United Kingdom, HA6 2RN
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: 5 fluorouracil
400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days
Drug: irinotecan
180mg/m2 iv day 1 every 14 days
Drug: levo- leucovorin
200mg/m2 iv; day 1 every 14 days
Drug: sunitinib
37.5mg of blinded therapy every day for 28 days followed by 14 days of blinded therapy free period
Placebo Comparator: 2
Drug: 5 fluorouracil
400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days
Drug: irinotecan
180mg/m2 iv day 1 every 14 days
Drug: levo- leucovorin
200mg/m2 iv; day 1 every 14 days
Drug: placebo
37.5mg of blinded placebo therapy every day for 28 days followed by 14 days of blinded therapy free period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS)
Time Frame: First dose of study treatment up to 30 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Baseline up to 30 months
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
Number of Participants With Overall Confirmed Objective Response
Time Frame: Day 28 of Cycle 1 up to 30 months
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
Duration of Response (DR)
Time Frame: Day 28 of Cycle 1 up to 30 months
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
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Assessment Inventory of Gastrointestinal Symptoms (MDASI-GI) Symptom Intensity Score
Time Frame: Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until end of treatment (EOT)/withdrawal
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
Change From Baseline in MDASI-GI Symptom Interference Score
Time Frame: Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal
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
Change From Baseline in European Quality of Life (EuroQol) EQ-5D Self-Report Questionnaire
Time Frame: Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal
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
Change From Baseline in EuroQol (EQ) Visual Analog Scale (VAS) (EQ-VAS)
Time Frame: Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

April 4, 2007

First Submitted That Met QC Criteria

April 5, 2007

First Posted (Estimate)

April 6, 2007

Study Record Updates

Last Update Posted (Estimate)

March 30, 2015

Last Update Submitted That Met QC Criteria

March 10, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6181122

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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