A Randomized, Phase 2B Study Of Sunitinib Plus Oxaliplatin, 5-Fluorouracil And Leucovorin (FOLFOX) Versus Bevacizumab Plus FOLFOX As First-Line Treatment In Patients With Metastatic Colorectal Cancer
The study was terminated on April 26, 2010 due to lack of efficacy, as determined during the
interim analysis of data in April 2010, showing that the study did not meet its primary
endpoint to demonstrate a statistically significant improvement in PFS. The decision to
terminate the trial was not based on any safety concerns.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free Survival (PFS)
Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
Baseline, at every 8-week intervals for 18 months then every 12 weeks thereafter until disease progression (up to Week 115)
No
Pfizer CT.gov Call Center
Study Director
Pfizer
United States: Food and Drug Administration
A6181104
NCT00609622
April 2008
July 2011
Name | Location |
---|---|
Pfizer Investigational Site | Birmingham, Alabama 35205 |
Pfizer Investigational Site | Blendora, California 91740 |
Pfizer Investigational Site | Atlanta, Georgia 30342 |
Pfizer Investigational Site | Springfield, Illinois 62701-1014 |
Pfizer Investigational Site | Houston, Texas 77030 |
Pfizer Investigational Site | Federal Way, Washington 98003 |
Pfizer Investigational Site | Flagstaff, Arizona 86001 |
Pfizer Investigational Site | North Little Rock, Arkansas 72117 |
Pfizer Investigational Site | Aurora, Colorado 80012 |
Pfizer Investigational Site | Clearwater, Florida 33761 |
Pfizer Investigational Site | Kansas City, Kansas 66112 |
Pfizer Investigational Site | Westminster, Maryland 21157 |
Pfizer Investigational Site | Columbia, Missouri 65201 |
Pfizer Investigational Site | Las Vegas, Nevada 89128 |
Pfizer Investigational Site | Bartlesville, Oklahoma 74006 |
Pfizer Investigational Site | Eugene, Oregon 97401 |
Pfizer Investigational Site | Kingston, Pennsylvania 18704-5535 |
Pfizer Investigational Site | Olive Branch, Mississippi 38654 |
Pfizer Investigational Site | Washington, District of Columbia 20007-2197 |