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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-02190 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dasatinib | Drug | Given orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | At 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | follow-up every 3 months for 30 months from first treatment or until disease recurrence or withdrawal of consent | |
| Disease-free survival | at 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Finn | Translational Oncology Research International | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Hematology Oncology Medical Group, Inc. | Alhambra | California | 91801 | United States | ||
| TORI FULLERTON (St. Jude Heritage Healthcare Virginia K. Crosson Cancer Center) |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 11, 2025 | |
| Reset | Jun 27, 2025 |
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| gemcitabine hydrochloride | Drug | Given IV |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| mutation analysis | Genetic | Correlative studies |
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| nucleic acid sequencing | Genetic | Correlative studies |
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|
| immunohistochemistry staining method | Other | Correlative studies |
|
|
| Fullerton |
| California |
| 92835 |
| United States |
| Pacific Shores Medical Group | Long Beach | California | 90813 | United States |
| UCLA medical center | Los Angeles | California | 90024-3417 | United States |
| Translational Oncology Research International (TORI) Network | Los Angeles | California | 90095 | United States |
| TORI NORTHRIDGE (North Valley Hematology/Oncology Medical Group) | Northridge | California | 91325 | United States |
| UCLA Pasadena | Pasadena | California | United States |
| TORI Inland Valley (Wilshire Oncology Medical Group, Inc. ) | Pomona | California | 91767 | United States |
| TORI REDONDO BEACH (Cancer Care Associates Medical Group, Inc.) | Redondo Beach | California | 90277 | United States |
| TORI SANTA BARBARA I (Santa Barbara Hematology Oncology Medical Group, Inc.) | Santa Barbara | California | 93105 | United States |
| TORI SANTA BARBARA II (SANSUM Clinic) | Santa Barbara | California | 93105 | United States |
| TORI SANTA MARIA (Central Coast Medical Oncology Corporation) | Santa Maria | California | 93454 | United States |
| UCLA Valencia | Valencia | California | United States |
| Suburban Hematology-Oncology Associates, P.A. | Lawrenceville | Georgia | 30045 | United States |
| Northwest Georgia Oncology Centers, P.C. | Marietta | Georgia | 30060 | United States |
| Chevy Chase Healthcare Management, LLC | Chevy Chase | Maryland | 20815 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89109 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 11, 2025 | Jun 27, 2025 |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069439 | Dasatinib |
| D000093542 | Gemcitabine |
| D001483 | Base Sequence |
| D007150 | Immunohistochemistry |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D015394 | Molecular Structure |
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |
| D006651 | Histocytochemistry |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
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