Clinical trial NCT00882765: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: adenocarcinoma of the pancreas
stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2009-04-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Changes in microvessel density of tumor specimen after 2 weeks of treatment with genistein
timeFrame: 2 weeks
Secondary outcomes:
measure: To evaluate the impact of genistein on the angiogenic factors VEGF, CXCL1, CXCL5, and CXCL8
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Edward Garon, MD
role: PRINCIPAL_INVESTIGATOR
References: