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Genistein in Treating Patients With Stage II, Stage III, or Stage IV Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
genistein
Sponsored by
UNC Lineberger Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer, recurrent prostate cancer

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed stage B, C, or D adenocarcinoma of the prostate not amenable to surgery PATIENT CHARACTERISTICS: Age: 40 and over Performance status: ECOG 0-2 Life expectancy: At least 6 months Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL Transaminases less than 4 times upper limit of normal Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease Other: No significant abnormalities of internal organs, neurologic status, or biochemical levels No history of seizures No concurrent serious illness No acute infection requiring antibiotic therapy except chronic urinary tract infection No other prior or concurrent malignancy within the past 2 years except nonmelanoma carcinoma of the skin No history of substance abuse or addiction No alcohol intake greater than 2 drinks/day or 14 drinks/week No diet containing more than 20 mg of genistein/day No known soy intolerance No prior breast cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: At least 3 months since prior hormonal therapy OR No concurrent estrogen Other concurrent hormonal therapy allowed if stable regimen for more than 3 months Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: See Disease Characteristics At least 3 weeks since prior surgery and recovered Other: At least 6 weeks since prior antibiotics No concurrent genotoxicity therapy

Sites / Locations

  • Lineberger Comprehensive Cancer Center, UNC

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 2, 2000
Last Updated
April 20, 2012
Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005827
Brief Title
Genistein in Treating Patients With Stage II, Stage III, or Stage IV Prostate Cancer
Official Title
Phase I Single and Multiple-Dose Safety and Pharmacokinetic Clinical Study of Genistein in Normal Volunteers and in Prostate Neoplasia (Multiple Dose Safety and Pharmacokinetic Clinical Study of Genistein in Prostate Neoplasia)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Withdrawn
Study Start Date
December 1999 (undefined)
Primary Completion Date
May 2003 (Actual)
Study Completion Date
May 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Randomized phase I trial to determine the effectiveness of genistein in treating patients who have stage II, stage III, or stage IV prostate cancer.
Detailed Description
OBJECTIVES: I. Determine the safety and pharmacokinetics of genistein in patients with stage II, III, or IV prostate cancer. OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral genistein twice daily. Arm II: Patients receive oral placebo twice daily. Treatment continues for 3 months in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer, recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
genistein

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage B, C, or D adenocarcinoma of the prostate not amenable to surgery PATIENT CHARACTERISTICS: Age: 40 and over Performance status: ECOG 0-2 Life expectancy: At least 6 months Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL Transaminases less than 4 times upper limit of normal Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease Other: No significant abnormalities of internal organs, neurologic status, or biochemical levels No history of seizures No concurrent serious illness No acute infection requiring antibiotic therapy except chronic urinary tract infection No other prior or concurrent malignancy within the past 2 years except nonmelanoma carcinoma of the skin No history of substance abuse or addiction No alcohol intake greater than 2 drinks/day or 14 drinks/week No diet containing more than 20 mg of genistein/day No known soy intolerance No prior breast cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: At least 3 months since prior hormonal therapy OR No concurrent estrogen Other concurrent hormonal therapy allowed if stable regimen for more than 3 months Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: See Disease Characteristics At least 3 weeks since prior surgery and recovered Other: At least 6 weeks since prior antibiotics No concurrent genotoxicity therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie Fischer, PhD, MPH, RD
Organizational Affiliation
UNC Lineberger Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Lineberger Comprehensive Cancer Center, UNC
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States

12. IPD Sharing Statement

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Genistein in Treating Patients With Stage II, Stage III, or Stage IV Prostate Cancer

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