Mitoxantrone Following Surgery in Treating Patients With Prostate Cancer at High Risk for Recurrence
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|ClinicalTrials.gov Identifier: NCT00003858|
Recruitment Status : Withdrawn (The study was not activated.)
First Posted : September 14, 2004
Last Update Posted : July 13, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: mitoxantrone hydrochloride||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Adjuvant Mitoxantrone (NSC #301739) for High Risk Patients Following Radical Prostatectomy|
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
- Decrease in time to failure [ Time Frame: Up to 3 years ]
- Decrease in the number of treatment failures [ Time Frame: Up to 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003858
|Study Chair:||Joseph C. Presti, MD||Stanford University|