Genistein In Treating Patients With Pancreatic Cancer That Can Be Removed By Surgery

Study Overview

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.

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.

Pancreatic Cancer

DIETARY_SUPPLEMENT: genistein

CDR0000639616
UCLA-0808100
NCI-2010-00242 (REGISTRY Identifier) (REGISTRY: CTRP)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-04-15	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-07-29
First Submitted that Met QC Criteria 2009-04-15	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-07-31
First Posted (ACTUAL) 2009-04-16	Results First Posted N/A	Last Verified 2012-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Supportive Care

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
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 Given orally
NO_INTERVENTION: No intervention Patients receive no specific neoadjuvant therapy.

Participant Group/Arm

Intervention/Treatment

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

Given orally

NO_INTERVENTION: No intervention

Patients receive no specific neoadjuvant therapy.

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

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Edward Garon, MD, Jonsson Comprehensive Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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