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Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00474812 |
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 |
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 |
Estimated Enrollment: | 49 |
Study Start Date: | May 2007 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the pancreas
PATIENT CHARACTERISTICS:
No condition that impairs ability to swallow and retain dasatinib tablets, including any of the following:
No clinically significant cardiovascular disease, including any of the following:
No concurrent uncontrolled illness, including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
No concurrent systemic antacids (i.e., H2-receptor antagonists and proton pump inhibitors)
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 |
Study Chair: | Joanna M. Brell, MD | Case Comprehensive Cancer Center |
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 |
adenocarcinoma of the pancreas stage IV pancreatic cancer recurrent pancreatic cancer |
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 |
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 |