Expired Study
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Kansas City, Kansas 66160


Purpose:

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Indole-3-carbinol may be effective in preventing breast cancer. PURPOSE: Phase I trial to study the effectiveness of indole-3-carbinol in preventing breast cancer in nonsmoking women who are at high risk for breast cancer.


Study summary:

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.


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 - Aspartate aminotransferase (AST) and Alanine transaminase (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


NCT ID:

NCT00033345


Primary Contact:

Study Chair
Aryeh Hurwitz, MD
University of Kansas Medical Center


Backup Contact:

N/A


Location Contact:

Kansas City, Kansas 66160
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 15, 2017

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