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

This study has been withdrawn prior to enrollment.
(Study has been closed due to no accrual.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00882765
First received: April 15, 2009
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Dietary Supplement: genistein
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Pre-Surgical, Randomized Clinical Trial of Genistein in Resectable Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • Changes in microvessel density of tumor specimen after 2 weeks of treatment with genistein [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the impact of genistein on the angiogenic factors VEGF, CXCL1, CXCL5, and CXCL8 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: May 2009
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive neoadjuvant oral genistein once daily for 2 weeks in the absence of disease progression or unacceptable toxicity.
Dietary Supplement: genistein
Given orally
No Intervention: No intervention
Patients receive no specific neoadjuvant therapy.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00882765

Locations
United States, California
UCLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: Edward Garon, MD Jonsson Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00882765     History of Changes
Other Study ID Numbers: CDR0000639616, P30CA016042, UCLA-0808100
Study First Received: April 15, 2009
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Jonsson Comprehensive Cancer Center:
adenocarcinoma of the pancreas
stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Genistein
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014