Dasatinib in Treating Patients With Stage IV Pancreatic Cancer

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Brief Title

Dasatinib in Treating Patients With Stage IV Pancreatic Cancer

Official Title

A Phase II Clinical Trial of Dasatinib in Patients With Metastatic Pancreatic Cancer

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Progression-free Survival (PFS) Rate at 4 Months

Secondary Outcome

 Response Rate

Condition

Pancreatic Cancer

Intervention

dasatinib

Study Arms / Comparison Groups

 Dasatinib
Description:  Dasatinib 70 mg po bid (1 cycle=28 days)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

7

Start Date

September 2007


Primary Completion Date

October 2012

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  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

        PATIENT CHARACTERISTICS:

          -  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

        PRIOR CONCURRENT THERAPY:

          -  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)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Vincent Chung, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00544908

Organization ID

07024

Secondary IDs

P30CA033572

Responsible Party

Sponsor

Study Sponsor

City of Hope Medical Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Vincent Chung, MD, Principal Investigator, City of Hope Comprehensive Cancer Center


Verification Date

September 2015