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
18 Years
N/A
Both
Metastatic Colorectal Cancer
Trial Information
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
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Progression-free Survival (PFS)
Outcome Description:
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.
Outcome Time Frame:
First dose of study treatment up to 30 months
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A6181122
NCT ID:
NCT00457691
Start Date:
June 2007
Completion Date:
March 2010
Related Keywords:
- Metastatic Colorectal Cancer
- colorectal neoplasms
- Colorectal Neoplasms
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