Genistein in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery
RATIONALE: Genistein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving genistein before surgery may be an effective treatment for pancreatic cancer.
PURPOSE: This randomized phase II trial is studying genistein to see how well it works in treating patients with pancreatic cancer that can be removed by surgery.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Pre-Surgical, Randomized Clinical Trial of Genistein in Resectable Pancreatic Adenocarcinoma|
- Changes in microvessel density of tumor specimen after 2 weeks of treatment with genistein [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- To evaluate the impact of genistein on the angiogenic factors VEGF, CXCL1, CXCL5, and CXCL8 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||May 2009|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive neoadjuvant oral genistein once daily for 2 weeks in the absence of disease progression or unacceptable toxicity.
Dietary Supplement: genistein
No Intervention: No intervention
Patients receive no specific neoadjuvant therapy.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00882765
|United States, California|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Edward Garon, MD||Jonsson Comprehensive Cancer Center|