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Dasatinib in Treating Patients With Metastatic Pancreatic Cancer
This study has been suspended.
First Received: May 16, 2007   Last Updated: May 7, 2009   History of Changes
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
Other: laboratory biomarker analysis
Other: physiologic testing
Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Dasatinib
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: May 2007
Estimated Primary Completion Date: October 2009 (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
Cleveland, Ohio, United States, 44106-5065
Geauga Regional Hospital
Cleveland, Ohio, United States, 44024
Lake/University Ireland Cancer Center
Cleveland, Ohio, United States, 44060
Mercy Cancer Center at Mercy Medical Center
Cleveland, Ohio, United States, 44708
University Suburban Health Center
Cleveland, Ohio, United States, 44121
UHHS Chagrin Highlands Medical Center
Cleveland, Ohio, United States, 44122
UHHS Westlake Medical Center
Cleveland, Ohio, United States, 44145
Southwest General Health Center
Cleveland, Ohio, United States, 44130
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Joanna M. Brell, MD Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Case Comprehensive Cancer Center ( Afshin Dowlati )
Study ID Numbers: CDR0000546554, CASE-5206, CASE 5206-CC204
Study First Received: May 16, 2007
Last Updated: May 7, 2009
ClinicalTrials.gov Identifier: NCT00474812     History of Changes
Health Authority: United States: Food and Drug Administration

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 Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancrelipase
Protein Kinase Inhibitors
Recurrence
Digestive System Diseases
Dasatinib
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Pancreatic Neoplasms
Endocrine System Diseases
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Dasatinib
Pancreatic Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009