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Multiple Daily Dose Phase I Safety And Pharmacokinetic Clinical Study Of Indole-3-Carbinol


Phase 1
18 Years
70 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Multiple Daily Dose Phase I Safety And Pharmacokinetic Clinical Study Of Indole-3-Carbinol


OBJECTIVES:

- Determine the safety and tolerability of indole-3-carbinol for the prevention of breast
cancer in non-smoking women at high risk for breast cancer.

- Determine the pharmacokinetics of this drug in these participants.

- Determine the effect of this drug on metabolites of estrogen in urine of these
participants.

- Determine other additional effects of this drug on selected indicators of drug
metabolism and reproductive and hormonal function in these participants.

- Assess any possible antineoplastic activity of this drug in these participants.

- Determine the quality of life of participants receiving this drug.

OUTLINE: This is a single-blind study.

Participants ingest study compound twice daily on weeks 1-12 or 1-16. Study compound is
dispensed on weeks 1, 5, and 9. At times, study compound is oral placebo, and at other
times, oral indole-3-carbinol.

Quality of life is assessed at baseline and then every 4 weeks during study therapy.

PROJECTED ACCRUAL: A total of 18 participants will be accrued for this study within 9
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Women at high risk for breast cancer, defined by at least 1 of the following
criteria:

- Projected 5-year probability of invasive breast cancer at least 1.66%, as
determined by the Breast Cancer Risk Assessment Tool

- Prior node-negative breast cancer

- Prior biopsy indicating atypical lobular or ductal hyperplasia or carcinoma in
situ

- Age 60 and over

- Non-smoker confirmed by urine cotinine test

- No concurrent breast cancer

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age:

- 18 to 70

Sex:

- Female

Menopausal status:

- Premenopausal (regular menstrual cycles of 24-36 days within the past 6 months) OR

- Postmenopausal (no menstrual cycle for at least 6 months)

Performance status:

- Not specified

Life expectancy:

- At least 1 year

Hematopoietic:

- Absolute granulocyte count greater than 1,500/mm^3

- Hemoglobin greater than 10 g/dL

Hepatic:

- Bilirubin less than 1.8 mg/dL

- AST and ALT less than 110 U/L

- Alkaline phosphatase less than 300 U/L

- Albumin greater than 3 g/dL

Renal:

- Creatinine less than 2.0 mg/dL

Cardiovascular:

- No acute or unstable cardiovascular condition based on electrocardiogram

Other:

- Mild seasonal allergies allowed

- No serious or life-threatening drug allergies

- No other serious intolerances or allergies

- No more than 20% above or below ideal body weight

- No acute or unstable medical condition by physical examination or laboratory tests

- No chronic headaches, dysphoria, fatigue, dizziness, blurred vision, insomnia,
rhinorrhea, nausea, vomiting, abdominal pain, diarrhea, constipation, or similar
conditions

- No serious illness requiring chronic drug therapy

- No active malignancy

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception 1 month before, during, and
for 1 month after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- At least 2 months since prior hormonal therapy as contraception or hormone
replacement therapy (HRT)

- No concurrent sex hormones as contraception for premenopausal women

- No concurrent HRT for postmenopausal women

Radiotherapy:

- Not specified

Surgery:

- Not specified

Other:

- At least 6 months since prior investigational drugs

- At least 1 month since prior weekly consumption of more than 3 medium servings (half
cup each) of cruciferous vegetables

- No concurrent vegetarian diet or weekly consumption of more than 3 medium servings
(half cup each) of cruciferous vegetables

- No continuous supplement intake

- No recent change in medications or dosage of medications

Type of Study:

Interventional

Study Design:

Primary Purpose: Prevention

Principal Investigator

Aryeh Hurwitz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Kansas

Authority:

United States: Federal Government

Study ID:

CDR0000069276

NCT ID:

NCT00033345

Start Date:

January 2002

Completion Date:

Related Keywords:

  • Breast Cancer
  • breast cancer
  • Breast Neoplasms

Name

Location

University of Kansas Medical CenterKansas City, Kansas  66160-7353