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Trial record 1 of 1 for:    NCT00457691
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Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00457691
Recruitment Status : Completed
First Posted : April 6, 2007
Results First Posted : June 3, 2011
Last Update Posted : March 30, 2015
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE April 4, 2007
First Posted Date  ICMJE April 6, 2007
Results First Submitted Date  ICMJE March 9, 2011
Results First Posted Date  ICMJE June 3, 2011
Last Update Posted Date March 30, 2015
Study Start Date  ICMJE June 2007
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 5, 2007)
Progression-free survival - defined as the time from the date of randomization to the date of the first documentation of objective tumour progression or death due to any cause, whichever occurs first.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2011)
  • 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.
  • 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.
  • 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.
  • 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).
  • 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).
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2007)
Overall survival - from randomization to the date of death due to any cause. Objective Response rate - proportion of patients with a confirmed complete or partial response. Duration of Response Adverse Events Patient Reported Outcomes
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Colorectal Cancer
Intervention  ICMJE
  • 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
  • Drug: placebo
    37.5mg of blinded placebo therapy every day for 28 days followed by 14 days of blinded therapy free period
Study Arms  ICMJE
  • Experimental: 1
    Interventions:
    • Drug: 5 fluorouracil
    • Drug: irinotecan
    • Drug: levo- leucovorin
    • Drug: sunitinib
  • Placebo Comparator: 2
    Interventions:
    • Drug: 5 fluorouracil
    • Drug: irinotecan
    • Drug: levo- leucovorin
    • Drug: placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2010)
768
Original Enrollment  ICMJE
 (submitted: April 5, 2007)
720
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE 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
Removed Location Countries Former Serbia and Montenegro,   Montenegro
 
Administrative Information
NCT Number  ICMJE NCT00457691
Other Study ID Numbers  ICMJE A6181122
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP