A Pre-Surgical, Randomized Clinical Trial of Genistein in Resectable Pancreatic Adenocarcinoma
- To determine changes in microvessel density of the tumor specimen after 2 weeks of
treatment with genistein in patients with resectable pancreatic adenocarcinoma.
- To evaluate the safety and tolerability of genistein in these patients by looking at
the impact of genistein on pancreatic cancer angiogenesis and on the angiogenic factors
VEGF, CXCL1, CXCL5, and CXCL8.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive neoadjuvant oral genistein once daily for 2 weeks in the
absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive no specific neoadjuvant therapy. In both arms, patients
undergo surgical resection in week 3.
Blood, urine, and tissue samples are collected at baseline and at the time of surgery for
laboratory biomarker studies. Samples are analyzed for VEGF, CXCL1, CXCL5, and CXCL8 by
ELISA and for genistein by mass spectrometry.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Changes in microvessel density of tumor specimen after 2 weeks of treatment with genistein
Edward Garon, MD
Jonsson Comprehensive Cancer Center
United States: Institutional Review Board
|UCLA||Los Angeles, California 90095|