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

NCT00457691

Last updated date
Study Location
Pfizer Investigational Site
La Plata, Buenos Aires, B1902AVQ, Argentina
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Colorectal Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
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 CenterPfizer
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