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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/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
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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
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Secondary ID [1]
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A6181122
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Colorectal Cancer
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Condition category
Condition code
Cancer
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0
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival (PFS)
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Assessment method [1]
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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.
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Timepoint [1]
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First dose of study treatment up to 30 months
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline up to 30 months
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Secondary outcome [2]
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Number of Participants With Overall Confirmed Objective Response
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Assessment method [2]
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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.
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Timepoint [2]
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Day 28 of Cycle 1 up to 30 months
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Secondary outcome [3]
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Duration of Response (DR)
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Assessment method [3]
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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.
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Timepoint [3]
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Day 28 of Cycle 1 up to 30 months
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Secondary outcome [4]
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Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Assessment Inventory of Gastrointestinal Symptoms (MDASI-GI) Symptom Intensity Score
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Assessment method [4]
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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).
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Timepoint [4]
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Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until end of treatment (EOT)/withdrawal
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Secondary outcome [5]
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Change From Baseline in MDASI-GI Symptom Interference Score
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Assessment method [5]
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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).
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Timepoint [5]
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Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal
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Secondary outcome [6]
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Change From Baseline in European Quality of Life (EuroQol) EQ-5D Self-Report Questionnaire
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Assessment method [6]
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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.
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Timepoint [6]
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Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal
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Secondary outcome [7]
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Change From Baseline in EuroQol (EQ) Visual Analog Scale (VAS) (EQ-VAS)
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Assessment method [7]
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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.
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Timepoint [7]
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Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2010
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Sample size
Target
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Accrual to date
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Final
768
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Pfizer Investigational Site - Wollongong
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Recruitment hospital [2]
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Pfizer Investigational Site - East Bentleigh
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Pfizer Investigational Site - Frankston
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Recruitment hospital [4]
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Pfizer Investigational Site - Fremantle
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Recruitment postcode(s) [1]
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2500 - Wollongong
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Recruitment postcode(s) [2]
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3165 - East Bentleigh
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Recruitment postcode(s) [3]
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3199 - Frankston
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Recruitment postcode(s) [4]
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6160 - Fremantle
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Recruitment outside Australia
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Argentina
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Buenos Aires
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Argentina
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Santa Fe
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Austria
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St. Poelten
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GO
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Ruse
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DF
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Mexico
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Forde
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Tonsberg
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Portugal
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Santa Maria da Feira
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Portugal
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Cluj
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Russian Federation
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Belgrade
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Sremska Kamenica
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Singapore
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Singapore
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Bratislava
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Observatory
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Panorama
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South Africa
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Port Elizabeth
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Alicante
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Zaragoza
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Cherkasy
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Dnipropetrovsk
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Ukraine
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Uzhgorod
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United Kingdom
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Middlesex
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London
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United Kingdom
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00457691
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Pfizer CT.gov Call Center
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Pfizer
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00457691
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