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Dasatinib in Treating Patients With Metastatic Pancreatic Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00474812
  Purpose

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 metastatic pancreatic cancer.


Condition Intervention Phase
Pancreatic Cancer
Drug: dasatinib
Procedure: laboratory biomarker analysis
Procedure: physiologic testing
Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Dasatinib Pancrelipase Ultrase
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of Dasatinib (BMS-354825) in Patients With Metastatic Adenocarcinoma of the Pancreas

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Median overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Fat-free mass [ Designated as safety issue: No ]
  • Gait speed [ Designated as safety issue: No ]
  • Therapeutic target markers [ Designated as safety issue: No ]

Estimated Enrollment: 49
Study Start Date: October 2006
Estimated Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the overall survival, including median survival, of patients with metastatic adenocarcinoma of the pancreas treated with dasatinib.

Secondary

  • Determine the effects of this drug on quantities of circulating tumor cells in these patients.
  • Determine the time to progression in patients treated with this drug.
  • Determine pre- and post-drug fat-free mass and gait speed in patients treated with this drug.
  • Evaluate the toxicity of this drug in these patients.
  • Evaluate objective response rate in patients treated with this drug.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection at baseline and during days 25-31. Samples are analyzed for quantification of circulating tumor cells. Patients also undergo analysis of fat-free mass and gait speed at baseline and at 1, 2, and 6 months.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: At total of 49 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the pancreas

    • Metastatic disease
  • Measurable or evaluable/nonmeasurable disease
  • No known brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
  • Life expectancy > 12 weeks
  • Absolute granulocyte count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin > 8.5 g/dL
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • Creatinine ≤ 2.0 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to dasatinib
  • No QTc prolongation (i.e., QTc interval ≥ 480 msecs [Fridericia correction]) or other significant ECG abnormalities
  • LVEF normal by MUGA scan
  • No condition that impairs ability to swallow and retain dasatinib tablets, including any of the following:

    • Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
    • Prior surgical procedures affecting absorption
    • Active peptic ulcer disease
  • No clinically significant cardiovascular disease, including any of the following:

    • Myocardial infarction or ventricular tachyarrhythmia within the past 6 months
    • Major conduction abnormality (unless a cardiac pacemaker is present)
  • No concurrent uncontrolled illness, including, but not limited to, any of the following:

    • Ongoing or active infection
    • History of significant bleeding disorder, including congenital (von Willebrand's disease) or acquired (anti-factor VIII antibodies) disorders
    • Large pleural effusions
    • Psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

  • Recovered from all prior therapy
  • More than 4 weeks since prior adjuvant chemotherapy (6 weeks for nitrosoureas or mitomycin C) and/or radiotherapy
  • No prior chemotherapy for metastatic disease
  • More than 4 weeks since prior EGFR inhibitors (e.g., imatinib mesylate, gefitinib, erlotinib hydrochloride, or lapatinib ditosylate)
  • No prior EGFR inhibitors that target Src kinases
  • More than 7 days since prior and no concurrent CYP3A4 inducers or inhibitors
  • At least 7 days since prior and no concurrent agents with proarrhythmic potential
  • No other concurrent investigational agents
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent grapefruit or grapefruit juice
  • No other concurrent anticancer agents or therapies
  • No concurrent systemic antacids (i.e., H2-receptor antagonists and proton pump inhibitors)

    • Locally acting antacids (e.g., Maalox, Mylanta) allowed within either 2 hours before or 2 hours after dasatinib therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00474812

Locations
United States, Ohio
Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Clinical Trials Office - Case Comprehensive Cancer Center     800-641-2422        
Geauga Regional Hospital Recruiting
Cleveland, Ohio, United States, 44024
Contact: Joanna M Brell     216-844-1676        
Lake/University Ireland Cancer Center Recruiting
Cleveland, Ohio, United States, 44060
Contact: Joanna M Brell     216-844-1676        
Mercy Cancer Center at Mercy Medical Center Recruiting
Cleveland, Ohio, United States, 44708
Contact: Joanna M Brell     216-844-1676        
University Suburban Health Center Recruiting
Cleveland, Ohio, United States, 44121
Contact: Joanna M Brell     216-844-1676        
UHHS Chagrin Highlands Medical Center Recruiting
Cleveland, Ohio, United States, 44122
Contact: Joanna M Brell     216-844-1676        
UHHS Westlake Medical Center Recruiting
Cleveland, Ohio, United States, 44145
Contact: Joanna M Brell     216-844-1676        
Southwest General Health Center Recruiting
Cleveland, Ohio, United States, 44130
Contact: Joanna M Brell     216-844-1676        
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Joanna M. Brell, MD Case Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000546554, CASE-5206, CASE 5206-CC204
Study First Received: May 16, 2007
Last Updated: December 16, 2008
ClinicalTrials.gov Identifier: NCT00474812  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the pancreas
stage IV pancreatic cancer
recurrent pancreatic cancer

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Dasatinib
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Adenocarcinoma
Pancrelipase
Recurrence
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009