Status:
WITHDRAWN
Genistein in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 effect...
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 *...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00882765
Start Date
May 1 2009
Last Update
July 31 2020
Active Locations (1)
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1
UCLA
Los Angeles, California, United States, 90095