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Dasatinib in Treating Patients With Stage IV Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00544908
Recruitment Status : Terminated (Toxicity)
First Posted : October 16, 2007
Results First Posted : September 17, 2015
Last Update Posted : October 5, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Tracking Information
First Submitted Date  ICMJE October 13, 2007
First Posted Date  ICMJE October 16, 2007
Results First Submitted Date  ICMJE August 19, 2015
Results First Posted Date  ICMJE September 17, 2015
Last Update Posted Date October 5, 2015
Study Start Date  ICMJE September 2007
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2015)
Progression-free Survival (PFS) Rate at 4 Months [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE
 (submitted: October 13, 2007)
Progression-free survival (PFS) at 4 months
Change History Complete list of historical versions of study NCT00544908 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2015)
Response Rate [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2007)
  • Response Rate
  • Quality of life
  • Median PFS
  • Overall survival
  • Safety and tolerability
  • Molecular correlates
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dasatinib in Treating Patients With Stage IV Pancreatic Cancer
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE
  • Drug: dasatinib
  • Other: immunoenzyme technique
  • Other: immunohistochemistry staining method
  • Other: laboratory biomarker analysis
  • Procedure: quality-of-life assessment
Study Arms  ICMJE Experimental: Dasatinib
Dasatinib 70 mg po bid (1 cycle=28 days)
Interventions:
  • Drug: dasatinib
  • Other: immunoenzyme technique
  • Other: immunohistochemistry staining method
  • Other: laboratory biomarker analysis
  • Procedure: quality-of-life assessment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 21, 2012)
7
Original Enrollment  ICMJE
 (submitted: October 13, 2007)
41
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00544908
Other Study ID Numbers  ICMJE 07024
P30CA033572 ( U.S. NIH Grant/Contract )
CHNMC-07024
BMS-CA180-114
CDR0000570288 ( Registry Identifier: NCI PDQ )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party City of Hope Medical Center
Study Sponsor  ICMJE City of Hope Medical Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Vincent Chung, MD City of Hope Comprehensive Cancer Center
PRS Account City of Hope Medical Center
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP