A Phase II Randomized, Open-Label, Multicenter Study Comparing CO-1.01 With Gemcitabine as First-Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic cancer is a very serious form of cancer. The majority of patients present with
unresectable disease, and the condition is often not diagnosed until the cancer is
relatively advanced. The standard first-line treatment for patients with unresectable
pancreatic cancer is gemcitabine monotherapy. Unfortunately many of these patients fail to
derive benefit from this treatment. No clinical or molecular marker has been established to
predict benefit from gemcitabine therapy, so patients are treated empirically until evidence
of disease progression or worsening performance status.
The potential for human equilibrative nucleoside transporter-1 (hENT1) expression to predict
survival in gemcitabine-treated patients has been studied, and data suggest that patients
with low levels of tumor cell hENT1 expression derive less benefit from gemcitabine
treatment than patients with high levels of tumor cell hENT1 expression. These data support
the hypothesis to be tested in this study that patients with pancreatic tumors expressing
low levels of hENT1 will derive minimal benefit from gemcitabine, but will receive benefit
from CO-1.01 (gemcitabine elaidate) which enters tumor cells in a hENT1-independent fashion.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival in patients with low hENT1 expression
Monthly follow up after treatment discontinuation until death
No
United States: Food and Drug Administration
CO-101-001
NCT01124786
May 2010
Name | Location |
---|---|
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Virginia Piper Cancer Institute | Minneapolis, Minnesota 55407 |
Wilshire Oncology Medical Group, Inc. | Rancho Cucamonga, California 91730 |
Rocky Mountain Cancer Centers | Thornton, Colorado 80260 |
Bend Memorial Clinic | Bend, Oregon 97701 |
Cancer Specialists of South Texas, P.A. | Corpus Christi, Texas 78412 |
The Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
Annapolis Oncology Center | Annapolis, Maryland 21401 |
Sharp Clinical Oncology Research | San Diego, California 92123 |
Cancer Center of the Carolinas | Greenville, South Carolina 29615 |
Oncology Associates of Bridgeport | Trumball, Connecticut 06611 |
New Mexico Cancer Care Alliance | Albuquerque, New Mexico 87106 |
South Texas Oncology and Hematology, PA | San Antonio, Texas 78229 |
Arena Oncology Associates, PC | Great Neck, New York 11021 |
Hematology Oncology Associates | Oakland, California 94609 |
Cancer Care Institute | Los Angeles, California 90036 |
Arizona Center for Hematology Oncology | Glendale, Arizona 85306 |
White Memorial Medical Center | Los Angeles, California 90033 |
Newport Cancer Care Medical | Newport Beach, California 92660 |
Hartford Hospital Clinical Research | Hartford, Connecticut 06102 |
Valley Cancer Associates | Harlingen, Texas 78550 |