Back to resultsGenistein in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery
Primary Purpose
Pancreatic Cancer
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
genistein
Sponsored by
About this trial
This is an interventional supportive care trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer
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
Sites / Locations
- UCLA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Arm I
No intervention
Arm Description
Patients receive neoadjuvant oral genistein once daily for 2 weeks in the absence of disease progression or unacceptable toxicity.
Patients receive no specific neoadjuvant therapy.
Outcomes
Primary Outcome Measures
Changes in microvessel density of tumor specimen after 2 weeks of treatment with genistein
Secondary Outcome Measures
To evaluate the impact of genistein on the angiogenic factors VEGF, CXCL1, CXCL5, and CXCL8
Full Information
NCT ID
NCT00882765
First Posted
April 15, 2009
Last Updated
July 29, 2020
Sponsor
Jonsson Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00882765
Brief Title
Genistein in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery
Official Title
A Pre-Surgical, Randomized Clinical Trial of Genistein in Resectable Pancreatic Adenocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Study has been closed due to no accrual.
Study Start Date
May 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
adenocarcinoma of the pancreas, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive neoadjuvant oral genistein once daily for 2 weeks in the absence of disease progression or unacceptable toxicity.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Patients receive no specific neoadjuvant therapy.
Intervention Type
Dietary Supplement
Intervention Name(s)
genistein
Intervention Description
Given orally
Primary Outcome Measure Information:
Title
Changes in microvessel density of tumor specimen after 2 weeks of treatment with genistein
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
To evaluate the impact of genistein on the angiogenic factors VEGF, CXCL1, CXCL5, and CXCL8
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Garon, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Genistein in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery
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