A Randomized, Open-Label Phase II/III Study of SU101 Plus Mitoxantrone/Prednisone Compared to Mitoxantrone/Prednisone Alone in Patients With Hormone-Refractory Prostate Cancer
OBJECTIVES: I. Compare the percentage one year survival rate in hormone refractory prostate
cancer patients treated with leflunomide (SU101), mitoxantrone, and prednisone versus
mitoxantrone and prednisone alone. II. Compare the palliative pain response, time to
treatment failure, time to progression, median survival, investigator global response
assessment, objective response, time to palliative pain response, duration of palliation,
and effect on PSA between these two regimens. III. Assess the safety and tolerability of
mitoxantrone in combination with SU101 in these patients. IV. Assess the health related
quality of life of these patients on these regimens.
OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified by
performance status (70-80% vs 90-100%), baseline present pain intensity score (2.0 vs
greater than 2.0), and hemoglobin level (less than 12.0 g/dL vs at least 12.0 g/dL).
Patients enter one of two treatment arms: Arm I: Patients are premedicated with an IV 5-HT3
reuptake inhibitor (i.e., odansetron) then receive mitoxantrone IV on day 1. Twice daily
oral prednisone therapy begins on day 1 and continues throughout study treatment. Treatment
repeats every 21 days for 4 courses. Arm II: Patients are premedicated with an IV 5-HT3
reuptake inhibitor as in arm I. Patients receive mitoxantrone and prednisone therapy as in
arm I. Additionally, beginning on day 1 patients receive leflunomide (SU101) IV over 4-5
hours weekly for 12 weeks. The SU101 infusions shall precede mitoxantrone infusions.
Patients receive a maximum of one year therapy with SU101; mitoxantrone therapy may be
administered up to a maximum dose of 140/m2. Quality of life is assessed at baseline, day 8,
day 21, and then every 3 weeks thereafter until study completion. Patients are followed at
least every 2 months.
PROJECTED ACCRUAL: Up to 370 patients will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Mack H. Mabry, MD
United States: Food and Drug Administration
|St. Vincents Comprehensive Cancer Center||New York, New York 10011|
|Florida Cancer Specialists||Fort Myers, Florida 33901|
|Comprehensive Cancer Care Specialists of Boca Raton||Boca Raton, Florida 33428|