Dasatinib in Treating Patients With Stage IV Pancreatic Cancer

Phase 2

Terminated

Conditions: Pancreatic Cancer

Interventions: Drug: dasatinib
Other: immunoenzyme technique
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Procedure: quality-of-life assessment

Registration Number: NCT00544908

Lead Sponsor: City of Hope Medical Center

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dasatinib	immunoenzyme technique	Dasatinib 70 mg po bid (1 cycle=28 days)
Dasatinib	laboratory biomarker analysis	Dasatinib 70 mg po bid (1 cycle=28 days)
Dasatinib	quality-of-life assessment	Dasatinib 70 mg po bid (1 cycle=28 days)
Dasatinib	immunohistochemistry staining method	Dasatinib 70 mg po bid (1 cycle=28 days)
Dasatinib	dasatinib	Dasatinib 70 mg po bid (1 cycle=28 days)

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS) Rate at 4 Months	Four months.	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).

Secondary Outcome Measures

Name	Time	Method
Response Rate	After every two cycles, up to 5 years	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

Trial Locations

Locations (2): City of Hope Comprehensive Cancer Center
🇺🇸
Duarte, California, United States
City of Hope Medical Group
🇺🇸
Pasadena, California, United States