Dasatinib in Treating Patients With Metastatic Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00474812
First received: May 16, 2007
Last updated: February 21, 2014
Last verified: November 2013

May 16, 2007
February 21, 2014
May 2007
January 2013   (final data collection date for primary outcome measure)
Median Overall Survival [ Time Frame: assessed up to 24 months ] [ Designated as safety issue: No ]
From the date of onset of treatment to the date of death and to the date of last follow-up for those still alive, assessed up to 24 months
Median overall survival
Complete list of historical versions of study NCT00474812 on ClinicalTrials.gov Archive Site
  • Objective Response Rate (Complete Response, Partial Response, or Stable Disease), Evaluated Using the New International Criteria Proposed by the RECIST Committee [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Response is defined as CR (Complete Response), PR (Partial Response) or SD (Stable Disease) per Response Evaluation Criteria in Solid Tumor (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions. SD: neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as progressive disease (PD). Progressive disease (PD) is defined as: at least a 20% increase in the sum of the LD of target lesions.
  • Median Progression Free Survival (PFS) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Number of months patients were free of disease progression, defined as < 20% increase in the sum of the LD of target lesions nor the appearance of one or more new lesions.
  • Gait Speed [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Gait speed, determined by a 4 meter walk along a properly measured stretch of hallway while being timed with a stopwatch.
  • Gait Speed [ Time Frame: at 8 weeks ] [ Designated as safety issue: No ]
    Gait speed, determined by a 4 meter walk along a properly measured stretch of hallway while being timed with a stopwatch.
  • Objective response rate
  • Time to progression
  • Overall survival
  • Fat-free mass
  • Gait speed
  • Therapeutic target markers
Not Provided
Not Provided
 
Dasatinib in Treating Patients With Metastatic Pancreatic Cancer
Phase II Study of Dasatinib (BMS-354825) in Patients With Metastatic Adenocarcinoma of the Pancreas

Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well dasatinib works in treating patients with metastatic pancreatic cancer.

PRIMARY OBJECTIVE:

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

SECONDARY OBJECTIVES:

I. Determine the effects of this drug on quantities of circulating tumor cells in these patients.

II. Determine the time to progression in patients treated with this drug. III. Determine pre- and post-drug fat-free mass and gait speed in patients treated with this drug.

IV. Evaluate the toxicity of this drug in these patients. V. 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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Adenocarcinoma of the Pancreas
  • Recurrent Pancreatic Cancer
  • Stage IV Pancreatic Cancer
  • Drug: dasatinib
    Other Names:
    • BMS-354825
    • Sprycel
  • Procedure: laboratory biomarker analysis
    Correlative study
  • Procedure: physiologic testing
    Correlative study
    Other Name: study of physiologic variables
Experimental: Dasatinib Treatment
Patients receive oral dasatinib twice daily on days 1-28.
Interventions:
  • Drug: dasatinib
  • Procedure: laboratory biomarker analysis
  • Procedure: physiologic testing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
February 2014
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the pancreas
  • Metastatic disease
  • Measurable or evaluable/nonmeasurable disease
  • No known brain metastases
  • ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
  • Life expectancy > 12 weeks
  • Absolute granulocyte count >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • 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
  • 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)
  • 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
  • At least 7 days since prior and no concurrent agents with proarrhythmic potential
  • 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]
  • 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
  • More than 7 days since prior and no concurrent CYP3A4 inducers or inhibitors
  • No other concurrent investigational agents
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00474812
NCI-2009-00228, NCI-2009-00228, CDR0000546554, CASE 5206, CASE 5206, 7828, U01CA062502
Yes
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Charles Nock Case Western Reserve University
National Cancer Institute (NCI)
November 2013

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