RO4929097 Before Surgery in Treating Patients With Pancreatic Cancer



Status:Archived
Conditions:Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:August 2010

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.A Neoadjuvant Pharmacodynamic Study Of RO4929097 (RO) in Pancreas Cancer


RATIONALE: RO4929097 may stop the growth of tumor cells by blocking some enzymes needed for
cell growth. Giving RO4929097 before surgery may make the tumor smaller and reduce the
amount of normal tissue that needs to be removed.

PURPOSE: This phase I trial is studying the side effects of RO4929097 before surgery in
treating patients with pancreatic cancer.


OBJECTIVES:

Primary

- To evaluate the effects of neoadjuvant gamma-secretase inhibitor RO4929097 on Notch
inhibition via interrogation of Hes-1 expression in patients with pancreatic cancer.

Secondary

- To evaluate the effects of this regimen on pancreatic cancer stem cell self-renewal and
tumorigenesis as compared to pancreatic stem cells from controls (patients who do not
receive treatment).

- To evaluate the safety of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral gamma-secretase inhibitor RO4929097 on days 1-3 and 8-11 in the
absence of disease progression or unacceptable toxicity. Beginning 7 days after completion
of gamma-secretase inhibitor RO4929097, patients undergo complete resection comprising
pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy based on the
anatomic location of the cancer.

Tumor tissue from biopsy and surgery and blood samples are collected for pharmacodynamic
studies.

After completion of study therapy, patients are followed up every 3 months for 1 year.


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Pasadena, California 91105
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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11143 Parkview Plaza Dr # 100
Fort Wayne, Indiana 46845
(260) 484-8830
Fort Wayne Medical Oncology and Hematology Fort Wayne Medical Oncology and Hematology provides state-of-the-art cancer...
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2279 45th Street
Sacramento, California 95817
(916) 734-5800
University of California Davis Cancer Center At UC Davis Comprehensive Cancer Center, specialized teams of...
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Ann Arbor, Michigan 48103
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Annandale, Virginia 22003
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Beverly Hills, California 90211
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2300 N. Edward Street
Decatur, Illinois 62526
217-876-8121
Decatur Memorial Hospital Cancer Care Institute An American flag bearing only 48 stars waved above...
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Evanston, Illinois 60201
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Los Angeles, California 90089
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2160 S. First Ave.
Maywood, Illinois 60153
888-584-7888
Cardinal Bernardin Cancer Center at Loyola University Medical Center The Cardinal Bernardin Cancer Center is...
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
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8940 Wood Sage Rd
Peoria, Illinois 61615
(309) 243-3000
Illinois CancerCare-Peoria Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
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Springfield, Illinois 62701
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