Mitoxantrone Following Surgery in Treating Patients With Prostate Cancer at High Risk for Recurrence
Recruitment status was Active, not recruiting
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy after surgery may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of mitoxantrone given after surgery in treating patients who have prostate cancer that is at high risk for recurrence.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Trial of Adjuvant Mitoxantrone (NSC #301739) for High Risk Patients Following Radical Prostatectomy|
OBJECTIVES: I. Assess the feasibility of enrolling patients with adenocarcinoma of the prostate at high risk for recurrence following radical prostatectomy in an adjuvant mitoxantrone trial. II. Determine if this adjuvant therapy results in a delay in time to failure or a decrease in the number of treatment failures compared to historical controls in this patient population.
OUTLINE: Patients receive mitoxantrone IV over 10-30 minutes every 21 days. Treatment continues for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for the first 3 years, and then every 6 months for the next 3 years or until disease progression.
PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study over 18 months.
|Study Chair:||Joseph C. Presti, MD||Stanford University|