RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving dasatinib together with gemcitabine hydrochloride is more effective than gemcitabine hydrochloride alone in treating pancreatic cancer. PURPOSE: This randomized phase II trial is studying how well giving dasatinib together with gemcitabine hydrochloride works compared to giving gemcitabine hydrochloride alone in treating patients with pancreatic cancer previously treated with surgery.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Given orally
Given IV
Correlative studies
Correlative studies
Correlative studies
Correlative studies
Central Hematology Oncology Medical Group, Inc.
Alhambra, California, United States
TORI FULLERTON (St. Jude Heritage Healthcare Virginia K. Crosson Cancer Center)
Fullerton, California, United States
Pacific Shores Medical Group
Long Beach, California, United States
UCLA medical center
Los Angeles, California, United States
Translational Oncology Research International (TORI) Network
Los Angeles, California, United States
TORI NORTHRIDGE (North Valley Hematology/Oncology Medical Group)
Northridge, California, United States
UCLA Pasadena
Pasadena, California, United States
TORI Inland Valley (Wilshire Oncology Medical Group, Inc. )
Pomona, California, United States
TORI REDONDO BEACH (Cancer Care Associates Medical Group, Inc.)
Redondo Beach, California, United States
TORI SANTA BARBARA I (Santa Barbara Hematology Oncology Medical Group, Inc.)
Santa Barbara, California, United States
...and 7 more locations
Disease-free survival
Time frame: At 18 months
Overall survival
Time frame: follow-up every 3 months for 30 months from first treatment or until disease recurrence or withdrawal of consent
Disease-free survival
Time frame: at 18 months
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