Clinical trialPhase 2Terminated
Dasatinib in Treating Patients With Stage IV Pancreatic Cancer
A Phase II Clinical Trial of Dasatinib in Patients With Metastatic Pancreatic Cancer
- Outcome
- Stopped earlyToxicity (Toxicity)
- Phase
- Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- September 2007
- Enrollment
- 7 participants
- Sites
- 2
- Primary outcomes
- Progression-free Survival (PFS) Rate at 4 Months
- Sponsor
- Other
- Results posted
- 2015-09-17
- Last update
- 5 October 2015
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
OBJECTIVES: Primary * To evaluate the 4-month progression-free survival (PFS) rate in patients with stage IV pancreatic cancer treated with dasatinib. Secondary * 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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Progression-free Survival (PFS) Rate at 4 Months [Four months.]. Number, percentage of participants. Dasatinib (n=7): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Response Rate [After every two cycles, up to 5 years]. Number, percentage of participants. Dasatinib (n=7): 0.