A Phase I/II Study of Adjuvant Prostate Irradiation and Ixabepilone For High Risk Prostate Cancer Post-Prostatectomy
- 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)
- 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
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.
Masking: Open Label, Primary Purpose: Treatment
Dose-limiting toxicity (phase I)
Simmons Cancer Center
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||Dallas, Texas 75390|