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

NCT00005827 | Withdrawn Phase 1 DMC

• 4 other identifiers: LCCC 9711UNC-GCRC-1203NCI-G00-1788CDR0000067840
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage II prostate cancer; stage III prostate cancer; stage IV prostate cancer; recurrent prostate cancer

Interventions

genistein DIETARY_SUPPLEMENT

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Genistein

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Isoflavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Leslie Fischer, PhD, MPH, RD

  UNC Lineberger Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: April 20, 2004
• Study Start: December 1, 1999
• Primary Completion: May 1, 2003
• Study Completion: May 1, 2003
• Last Updated: April 24, 2012

Record last verified: 2012-04

Locations

US (1)