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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)


Phase 1
40 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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)


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.

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Leslie Fischer, PhD, MPH, RD

Investigator Role:

Study Chair

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

LCCC 9711

NCT ID:

NCT00005827

Start Date:

December 1999

Completion Date:

May 2003

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage II prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location

Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295