A Phase II Clinical Trial of Dasatinib in Patients With Metastatic Pancreatic Cancer
- To evaluate the 4-month progression-free survival (PFS) rate in patients with stage IV
pancreatic cancer treated with dasatinib.
- To evaluate the response rate (complete and partial response) in patients treated with
- To evaluate the median PFS and overall survival of patients treated with this drug.
- To study the toxicities and tolerability of this drug in these patients.
- To evaluate the impact of this drug on quality of life measures.
- To evaluate the impact of this drug on Src and FAK in peripheral blood mononuclear
cells prior to and during treatment.
- To study the pre-treatment expression of various signaling molecules in the Src and
STAT3 pathways and attempt to identify a relationship between these findings and the
aggressiveness of the tumor or its response to treatment with dasatinib.
OUTLINE: This is a multicenter study.
Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.
Patients undergo tumor tissue and blood sample collection periodically for correlative and
biological studies. Blood samples are analyzed for phosphorylation levels of proteins,
including phospho-Src, phospho-Fak, and other relevant biomarkers, by western blotting.
Tumor tissue samples are analyzed for biomarkers by immunohistochemistry.
Quality of life is assessed at baseline, after every other course during treatment, and then
at 1 year after treatment using the FACT-HEP questionnaire.
After completion of study treatment, patients are followed every 2 months.
Masking: Open Label, Primary Purpose: Treatment
Progression-free survival (PFS) at 4 months
Vincent Chung, MD
Beckman Research Institute
United States: Federal Government
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|
|City of Hope Medical Group||Pasadena, California 91105|