Study Stopped
Study has been closed due to no accrual.
Genistein in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery
A Pre-Surgical, Randomized Clinical Trial of Genistein in Resectable Pancreatic Adenocarcinoma
3 other identifiers
interventional
N/A
1 country
1
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.
Trial Health
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1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2009
CompletedFirst Posted
Study publicly available on registry
April 16, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedJuly 31, 2020
July 1, 2012
1.7 years
April 15, 2009
July 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in microvessel density of tumor specimen after 2 weeks of treatment with genistein
2 weeks
Secondary Outcomes (1)
To evaluate the impact of genistein on the angiogenic factors VEGF, CXCL1, CXCL5, and CXCL8
3 weeks
Study Arms (2)
Arm I
EXPERIMENTALPatients receive neoadjuvant oral genistein once daily for 2 weeks in the absence of disease progression or unacceptable toxicity.
No intervention
NO INTERVENTIONPatients receive no specific neoadjuvant therapy.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCLA
Los Angeles, California, 90095, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edward Garon, MD
Jonsson Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2009
First Posted
April 16, 2009
Study Start
May 1, 2009
Primary Completion
January 1, 2011
Last Updated
July 31, 2020
Record last verified: 2012-07