Genistein in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery

NCT ID: NCT00882765

Last Updated: 2020-07-31

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm I

Patients receive neoadjuvant oral genistein once daily for 2 weeks in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

genistein

Intervention Type: DIETARY_SUPPLEMENT

Given orally

No intervention

Patients receive no specific neoadjuvant therapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

genistein

Given orally

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward Garon, MD

Role: PRINCIPAL_INVESTIGATOR

Jonsson Comprehensive Cancer Center

Locations

UCLA

Los Angeles, California, United States

Countries

United States

Other Identifiers

UCLA-0808100

Identifier Type: -

Identifier Source: secondary_id

NCI-2010-00242

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000639616

Identifier Type: -

Identifier Source: org_study_id