Back to resultsDasatinib in Treating Patients With Metastatic Pancreatic Cancer
Primary Purpose
Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage IV Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
dasatinib
laboratory biomarker analysis
physiologic testing
Sponsored by
About this trial
This is an interventional treatment trial for Adenocarcinoma of the Pancreas
Eligibility Criteria
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
Sites / Locations
- Case Western Reserve University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dasatinib Treatment
Arm Description
Patients receive oral dasatinib twice daily on days 1-28.
Outcomes
Primary Outcome Measures
Median Overall Survival
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
Secondary Outcome Measures
Objective Response Rate (Complete Response, Partial Response, or Stable Disease), Evaluated Using the New International Criteria Proposed by the RECIST Committee
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)
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
Gait speed, determined by a 4 meter walk along a properly measured stretch of hallway while being timed with a stopwatch.
Gait Speed
Gait speed, determined by a 4 meter walk along a properly measured stretch of hallway while being timed with a stopwatch.
Full Information
NCT ID
NCT00474812
First Posted
May 16, 2007
Last Updated
April 14, 2015
Sponsor
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00474812
Brief Title
Dasatinib in Treating Patients With Metastatic Pancreatic Cancer
Official Title
Phase II Study of Dasatinib (BMS-354825) in Patients With Metastatic Adenocarcinoma of the Pancreas
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage IV Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dasatinib Treatment
Arm Type
Experimental
Arm Description
Patients receive oral dasatinib twice daily on days 1-28.
Intervention Type
Drug
Intervention Name(s)
dasatinib
Other Intervention Name(s)
BMS-354825, Sprycel
Intervention Type
Procedure
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative study
Intervention Type
Procedure
Intervention Name(s)
physiologic testing
Other Intervention Name(s)
study of physiologic variables
Intervention Description
Correlative study
Primary Outcome Measure Information:
Title
Median Overall Survival
Description
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
Time Frame
assessed up to 24 months
Secondary Outcome Measure Information:
Title
Objective Response Rate (Complete Response, Partial Response, or Stable Disease), Evaluated Using the New International Criteria Proposed by the RECIST Committee
Description
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.
Time Frame
Up to 5 years
Title
Median Progression Free Survival (PFS)
Description
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.
Time Frame
Up to 5 years
Title
Gait Speed
Description
Gait speed, determined by a 4 meter walk along a properly measured stretch of hallway while being timed with a stopwatch.
Time Frame
baseline
Title
Gait Speed
Description
Gait speed, determined by a 4 meter walk along a properly measured stretch of hallway while being timed with a stopwatch.
Time Frame
at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Nock
Organizational Affiliation
Case Western Reserve University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dasatinib in Treating Patients With Metastatic Pancreatic Cancer
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