Finding studies
Finding studies
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Lead
Vanderbilt-Ingram Cancer Center
With
OBJECTIVES: Primary * Evaluate the safety and efficacy of ABT-751 in patients with androgen-independent, hormone-refractory metastatic prostate cancer and determine the maximum tolerated dose (MTD) and optimal phase II dose of this drug in these patients. Secondary * Determine the objective response rate (partial and complete response) in patients with measurable disease treated with this drug. * Evaluate the effect of this drug on prostate-specific antigen (PSA) response in patients with nonmeasurable disease. * Determine the time to tumor progression in patients treated with this drug. * Determine survival of patients treated with this drug. * Determine the toxicity of this drug in these patients. OUTLINE: This is a phase I, dose-escalation study followed by a phase II study. * Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ABT-751 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 50 additional patients may be treated at the recommended phase II dose (RPTD) which is the dose level at the maximally administered dose. * Phase II: Patients receive ABT-751 at the MTD determined in phase I. After completion of study treatment, patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
