A Multicenter, Open-Label, Randomized, Phase II Trial of Adjuvant Dasatinib Plus Gemcitabine Versus Single-Agent Gemcitabine in Patients With Resected Pancreatic Adenocarcinoma
PRIMARY OBJECTIVES: I. To compare disease-free survival at 18 months between
dasatinib-gemcitabine combination therapy and single-agent gemcitabine. SECONDARY
OBJECTIVES: I. To evaluate effects on disease-free survival of the dasatinib-gemcitabine
combination therapy compared with gemcitabine alone for adjuvant treatment of resected
pancreatic adenocarcinoma. II. To evaluate effects on overall survival of
dasatinib-gemcitabine combination therapy compared with gemcitabine alone for adjuvant
treatment of resected pancreatic adenocarcinoma. III. To evaluate tolerability and safety of
the two arms. IV. To identify potential biological correlates associated with clinical
benefit to dasatinib-gemcitabine combination therapy compared with gemcitabine alone.
OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive
gemcitabine hydrochloride IV on days 1, 8, and 15. Treatment repeats every 28 days for 6
courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients
receive gemcitabine hydrochloride IV on days 1, 8, and 15 and oral dasatinib once daily on
days 1-28. Treatment repeats every 28 days for 6 courses* in the absence of disease
progression or unacceptable toxicity. NOTE: * Courses with dasatinib repeat every 28 days
for 1 year in the absence of disease progression or unacceptable toxicity. After completion
of study treatment, patients are followed up every 3 months for 2 years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease-free survival
At 18 months
No
Richard Finn
Principal Investigator
Translational Oncology Research International
United States: Food and Drug Administration
TRIO-TORI PA-01
NCT01234935
October 2010
Name | Location |
---|---|
Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada 89109 |
Pacific Shores Medical Group | Long Beach, California 90813 |
UCLA Medical Center | Los Angeles, California 90095-7059 |
Northwest Georgia Oncology Centers, P.C. | Marietta, Georgia 30060 |
Central Hematology Oncology Medical Group, Inc. | Alhambra, California 91801 |
Suburban Hematology-Oncology Associates, P.A. | Lawrenceville, Georgia 30045 |
Translational Oncology Research International (TORI) Network | Los Angeles, California 90095 |
Chevy Chase Healthcare Management, LLC | Chevy Chase, Maryland 20815 |
TORI REDONDO BEACH (Cancer Care Associates Medical Group, Inc.) | Redondo Beach, California 90277 |
TORI FULLERTON (St. Jude Heritage Healthcare Virginia K. Crosson Cancer Center) | Fullerton, California 92835 |
TORI NORTHRIDGE (North Valley Hematology/Oncology Medical Group) | Northridge, California 91325 |
UCLA Pasadena | Pasadena, California |
TORI Inland Valley (Wilshire Oncology Medical Group, Inc. ) | Pomona, California 91767 |
TORI SANTA BARBARA I (Santa Barbara Hematology Oncology Medical Group, Inc.) | Santa Barbara, California 93105 |
TORI SANTA BARBARA II (SANSUM Clinic) | Santa Barbara, California 93105 |
TORI SANTA MARIA (Central Coast Medical Oncology Corporation) | Santa Maria, California 93454 |
UCLA Valencia | Valencia, California |