Genistein in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
OBJECTIVES: Primary To determine changes in microvessel density of the tumor specimen after 2 weeks of treatment with genistein in patients with resectable pancreatic adenocarcinoma. Secondary 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.

Official Title
-----------------
A Pre-Surgical, Randomized Clinical Trial of Genistein in Resectable Pancreatic Adenocarcinoma

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Dietary Supplement: genistein


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults over the age of 18 capable of giving informed consent resectable pancreatic mass, known or presumed to be primary pancreatic adenocarcinoma. Patients whose initial biopsy do not show adenocarcinoma will not receive the study drug. ECOG preformance status 0-2. Negative pregnancy test prior to initiation of treatment and adequate contraception throughout treatment. Exclusion criteria: comorbid disease or medical condition that would impair the ability of the patient to receive or comply with the study protocol hypersensitivity to genistein or to any of the excipients of genistein prior chemotherapy or radiotherapy for pancreatic adenocarcinoma concomitant use of warfarin, tamoxifen, or raloxifene. pregnancy or inadequate contraception. lactating females

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients receive neoadjuvant oral genistein once daily for 2 weeks in the absence of disease progression or unacceptable toxicity. | Dietary Supplement: genistein<br>* Given orally<br>|
| No Intervention: No intervention<br>Patients receive no specific neoadjuvant therapy. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in microvessel density of tumor specimen after 2 weeks of treatment with genistein |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the impact of genistein on the angiogenic factors VEGF, CXCL1, CXCL5, and CXCL8 |  | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adenocarcinoma of the pancreas, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer