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A Pre-Surgical, Randomized Clinical Trial of Genistein in Resectable Pancreatic Adenocarcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

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Trial Information

A Pre-Surgical, Randomized Clinical Trial of Genistein in Resectable Pancreatic Adenocarcinoma


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Changes in microvessel density of tumor specimen after 2 weeks of treatment with genistein

Outcome Time Frame:

2 weeks

Safety Issue:

No

Principal Investigator

Edward Garon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CDR0000639616

NCT ID:

NCT00882765

Start Date:

May 2009

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • adenocarcinoma of the pancreas
  • stage I pancreatic cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • Adenocarcinoma
  • Pancreatic Neoplasms

Name

Location

UCLALos Angeles, California  90095