Adenocarcinoma of the Pancreas Clinical Trial
Official title:
A Neoadjuvant Pharmacodynamic Study Of RO4929097 (RO) in Pancreas Cancer
This phase I trial is studying the side effects of RO4929097 before surgery in treating patients with pancreatic cancer. 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.
PRIMARY OBJECTIVES:
I. 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 OBJECTIVES:
I. 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).
II. 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 8-10 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 periodically for pharmacodynamic studies.
After completion of study therapy, patients are followed up every 6 months for 1 year.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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