APRiCOT-P (Apricoxib in Combination Oncology Treatment - Pancreas): Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Gemcitabine and Erlotinib in the Treatment of Patients With Advanced Pancreatic Cancer
This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with
placebo and gemcitabine/erlotinib as measured by progression-free survival to test the
hypothesis that down regulation of COX-2 and EGFR pathways in patients with up-regulated
COX-2 expression in tumors will have a clinical benefit compared with Gemcitabine/Erlotinib
only.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Progression Free Survival
Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.
Randomization then every other cycle
No
Tracy Parrott
Study Director
Tragara Pharmaceuticals, Inc.
United States: Food and Drug Administration
TP2001-203
NCT00709826
August 2008
May 2011
Name | Location |
---|---|
Warren Hospital | Phillipsburg, New Jersey 08865 |
Hematology Oncology Associates | Atlantis, Florida 33462 |
Front Range Cancer Specialists | Fort Collins, Colorado 80528 |
Comprehensive Blood and Cancer Center | Bakersfield, California 93309 |
Arizona Clinical Research Center | Tucson, Arizona 85712 |
Southeastern Medical Oncology Center | Goldsboro, North Carolina 27534 |
Tennessee Cancer Specialists | Knoxville, Tennessee 37920 |
Nebraska Methodist Hospital | Omaha, Nebraska 68114 |
Cascade Cancer Center | Kirkland, Washington 98034-3013 |
Medical Consultants, PC | Muncie, Indiana 47304 |
The Methodist Hospital | Houston, Texas 77030 |
The Center for Cancer and Blood Disorders | Fort Worth, Texas 76104 |
Bay Area Cancer Research Group, LLC | Concord, California 94520 |
San Juan Oncology Associates | Farmington, New Mexico 87401 |
Hematology Oncology Associates of Treasure Coast | Port St. Lucie, Florida 34952 |
The Jones Clinic | Germantown, Tennessee 38138 |
Oncology Associates of Bridgeport | Trumball, Connecticut 06611 |
Southbay Oncology Hematology Partners | Campbell, California 95008 |
Coastal Bend Cancer Center | Corpus Christi, Texas 78404 |
Investigative Clinical Research of Indiana, LLC | Indianapolis, Indiana 46254 |
Charleston Hematology Oncology Associates | Charleston, South Carolina 29403 |
North America Research Institute | San Dimas, California |
SJMH Cancer Center | Ann Arbor, Michigan |
Eastern Regional Medical Center | Philadelphia, Pennsylvania |
Associates in Hematology-Oncology PC | Upland, Pennsylvania |
University of Iowa Hospitals | Iowa City, Iowa 52242 |
Owsley Brown Frazier Cancer Center | Louisville, Kentucky 40245 |
Bronx River Medical Associates, P.C. | Bronx, New York 10467 |
The Queen's Medical Center Cancer Center | Honolulu, Hawaii 96813 |
Rush-Copley Medical Center | Aurora, Illinois 60504 |
Alexian Brothers Medical Hospital Network | Elk Grove Village, Illinois 60007 |
Jayne Gurtler, MD | Metairie, Louisiana 70006 |
Franklin Square Hospital Center/Harry and Jeanette Weinberg Cancer Institute at Franklin Square | Baltimore, Maryland 21237 |
Cancer Care of WNC, PA | Asheville, North Carolina 28801 |
Samaritan Hematology * Oncology | Corvallis, Oregon 97330 |
Berks Hematology-Oncology Associates, Ltd | West Reading, Pennsylvania 19612 |
JTV Cancer Care Institute | Rapid City, South Dakota 57701 |