Finding studies
Finding studies
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Lead
University of Texas Southwestern Medical Center
With
OBJECTIVES: Primary * To determine the maximum-tolerated dose and dose-limiting toxicity of ixabepilone in combination with concurrent intensity-modulated radiation therapy in patients with high-risk prostate cancer after prostatectomy. (Phase I) * To determine the toxicity profile of this regimen in these patients. (Phase I) Secondary * To assess freedom from progression in patients treated with this regimen. (Phase II) * To assess biochemical failure, local failure, and distant failure in patients treated with this regimen. (Phase II) * To assess disease-specific survival and overall survival of patients treated with this regimen. (Phase II) * To evaluate acute and late toxicity of this regimen in these patients. OUTLINE: This is a phase I, dose-escalation study of ixabepilone followed by a phase II study. Patients undergo adjuvant intensity-modulated radiation therapy once daily, 5 days a week, for 7-9 weeks. Patients also receive concurrent ixabepilone IV over 1 hour on days 1 and 8. Treatment with ixabepilone repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up every 3 months for 1 year, every 6 months for 3 years, and then annually for 6 years.
Age
18–120
Sex
MALE
Healthy volunteers
Not accepted
