Dasatinib in Treating Patients With Stage IV Pancreatic Cancer
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with stage IV pancreatic cancer.
Other: immunoenzyme technique
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Procedure: quality-of-life assessment
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Clinical Trial of Dasatinib in Patients With Metastatic Pancreatic Cancer|
- Progression-free Survival (PFS) Rate at 4 Months [ Time Frame: Four months. ] [ Designated as safety issue: No ]Progressive disease - appearance of one or more new lesions. Unequivocal progression of existing non-target lesions. Although a clear progression of non-target lesions only is exceptional, in such circumstances, the opinion of the treating physician should prevail and the progression status should be confirmed later on by a review panel (or study chair/primary investigator).
- Response Rate [ Time Frame: After every two cycles, up to 5 years ] [ Designated as safety issue: No ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
|Study Start Date:||September 2007|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Dasatinib 70 mg po bid (1 cycle=28 days)
|Drug: dasatinib Other: immunoenzyme technique Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: quality-of-life assessment|
- 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 this drug.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00544908
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|City of Hope Medical Group|
|Pasadena, California, United States, 91105|
|Principal Investigator:||Vincent Chung, MD||City of Hope Comprehensive Cancer Center|