Dasatinib in Treating Patients With Metastatic Pancreatic Cancer
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.
Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage IV Pancreatic Cancer
Procedure: laboratory biomarker analysis
Procedure: physiologic testing
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Dasatinib (BMS-354825) in Patients With Metastatic Adenocarcinoma of the Pancreas|
- 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
- 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.
|Study Start Date:||May 2007|
|Study Completion Date:||February 2014|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Experimental: Dasatinib Treatment
Patients receive oral dasatinib twice daily on days 1-28.
Other Names:Procedure: laboratory biomarker analysis
Correlative studyProcedure: physiologic testing
Other Name: study of physiologic variables
I. Determine the overall survival, including median survival, of patients with metastatic adenocarcinoma of the pancreas treated with dasatinib.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00474812
|United States, Ohio|
|Case Western Reserve University|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Charles Nock||Case Western Reserve University|