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

NCT ID: NCT00005827

Last Updated: 2012-04-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-12-31
• Study Completion Date: 2003-05-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

genistein

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leslie Fischer, PhD, MPH, RD

Role: STUDY_CHAIR

UNC Lineberger Comprehensive Cancer Center

Locations

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

UNC-GCRC-1203

Identifier Type: -

Identifier Source: secondary_id

NCI-G00-1788

Identifier Type: -

Identifier Source: secondary_id

CDR0000067840

Identifier Type: OTHER

Identifier Source: secondary_id

LCCC 9711

Identifier Type: -

Identifier Source: org_study_id