Mitoxantrone Following Surgery in Treating Patients With Prostate Cancer at High Risk for Recurrence
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:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Adjuvant Mitoxantrone (NSC #301739) for High Risk Patients Following Radical Prostatectomy|
- Decrease in time to failure [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
- Decrease in the number of treatment failures [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
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.
|Drug: mitoxantrone hydrochloride|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003858
|Study Chair:||Joseph C. Presti, MD||Stanford University|