Dasatinib In Treating Patients With Stage IV Pancreatic Cancer

Study Overview

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.

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.

Pancreatic Cancer

DRUG: dasatinib
OTHER: immunoenzyme technique
OTHER: immunohistochemistry staining method
OTHER: laboratory biomarker analysis
PROCEDURE: quality-of-life assessment

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Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2007-10-13	Results First Submitted 2015-08-19	Last Update Submitted that met QC Criteria 2015-09-18
First Submitted that Met QC Criteria 2007-10-13	Results First Submitted that Met QC Criteria 2015-08-19	Last Update Posted (ESTIMATED) 2015-10-05
First Posted (ESTIMATED) 2007-10-16	Results First Posted 2015-09-17	Last Verified 2015-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Dasatinib 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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Dasatinib

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

Primary Outcome Measures	Measure Description	Time Frame
Progression-free Survival (PFS) Rate at 4 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).	Four months.

Secondary Outcome Measures	Measure Description	Time Frame
Response Rate	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	After every two cycles, up to 5 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically
confirmed pancreatic cancer

Stage IV disease NOTE: *If biopsy was performed at an outside facility, the histology must be reviewed and confirmed by the Division of Pathology at the City of Hope

Karnofsky performance status 60-100%
Life expectancy ≥ 3 months
Platelet count ≥ 100,000/μL
Absolute neutrophil count ≥ 1,500/μL
Bilirubin ≤ 1.5 mg/dL
ALT and AST ≤ 2.5 times upper limit of normal (ULN)
Creatinine ≤ 1.5 mg/dL and/or creatinine clearance > 60 mL/min
PT and PTT ≤ 1.5 times ULN
Able to swallow dasatinib whole
No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix, uterus, or bladder
No concurrent medical condition which may increase the risk of toxicity, including any of the following:

Pleural or pericardial effusion of any grade
Clinically significant coagulation or platelet function disorder (e.g., known von Willebrand's disease)
None of the following cardiac conditions:

Uncontrolled angina, congestive heart failure, or myocardial infarction within the past 6 months
Prolonged QTc interval (i.e., QTc > 450 msec) on electrocardiogram
History of clinically significant ventricular arrhythmias (i.e., ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
No hypokalemia or hypomagnesemia that cannot be corrected
No severe infection requiring treatment
Completely recovered from other concurrent illnesses, as deemed by the investigator
Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception

Recovered from prior major surgery
No prior irradiation to the planned field
No prior chemotherapy for pancreatic cancer
At least 7 days since prior and no concurrent medications that may prolong the QT interval, including any of the following:

Quinidine
Procainamide
Disopyramide
Amiodarone
Sotalol
Ibutilide
Dofetilide
Erythromycin
Clarithromycin
Chlorpromazine
Haloperidol
Mesoridazine
Thioridazine
Pimozide
Cisapride
Bepridil
Droperidol
Methadone
Arsenic
Chloroquine
Domperidone
Halofantrine
Levomethadyl
Pentamidine
Sparfloxacin
Lidoflazine
At least 7 days since prior and no concurrent potent CYP3A4 inhibitors
At least 7 days since prior and no concurrent medications that directly and durably inhibit platelet function, including any of the following:

Aspirin or aspirin-containing combinations
Clopidogrel
Dipyridamole
Tirofiban
Dipyridamole
Epoprostenol
Eptifibatide
Cilostazol
Abciximab
Ticlopidine
Cilostazol
No concurrent anticoagulants, including warfarin or heparin/low molecular weight heparin (e.g., danaparoid, dalteparin, tinzaparin, or enoxaparin)

Low-dose warfarin for prophylaxis to prevent catheter thrombosis or heparin for flushes of IV lines allowed
No concurrent IV bisphosphonates during the first 8 weeks of dasatinib therapy
No concurrent Hypericum perforatum (St. Johns wort)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

PRINCIPAL_INVESTIGATOR: Vincent Chung, MD, City of Hope Comprehensive Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record