Phase I/II Study of Neoadjuvant Weekly Docetaxel and Mitoxantrone Prior to Prostatectomy in Patients With High Risk Localized Prostate Cancer
- Determine the 5-year freedom from prostate-specific antigen (PSA) recurrence in
patients treated with this regimen.
- Define the maximum tolerated dose of neoadjuvant docetaxel and mitoxantrone followed by
prostatectomy in patients with high-risk localized prostate cancer. (Phase I completed
as of 2/15/02)
- Determine the toxicity of this regimen in these patients.
- Determine the PSA response rate and pathologic response rate in patients treated with
- Determine the clinical response in patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the surgical margin status at time of prostatectomy in patients treated with
OUTLINE: This is a dose-escalation study of mitoxantrone. (Phase I completed as of 2/15/02)
Patients receive neoadjuvant docetaxel and mitoxantrone weekly on weeks 1-3. Treatment
repeats once a week for a total of 4 courses.
Patients receive escalating doses of mitoxantrone until the maximum tolerated dose is
determined. (Phase I completed as of 2/15/02)
Patients undergo prostatectomy 2-4 weeks after completion of neoadjuvant chemotherapy.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With 5-year Freedom From Prostate Specific Antigen (PSA) Recurrence.
Number of participants that experienced 5-year freedom from Prostate Specific Antigen (PSA) recurrence (PSA > 0.4 ng/ml confirmed by a second PSA that is higher than the first by any amount (2)) in men with high risk localized prostate cancer treated with neoadjuvant docetaxel/mitoxantrone followed by surgery.
Every 3 months after surgery for up to 5 years.
Tomasz M. Beer, MD
OHSU Knight Cancer Institute
United States: Federal Government
|OHSU Knight Cancer Institute||Portland, Oregon 97239|
|Portland VA Medical Center||Portland, Oregon 97239|