Combination Chemotherapy Followed by Surgery in Treating Patients With Localized Prostate Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy followed by surgery in treating patients who have localized prostate cancer.
Drug: mitoxantrone hydrochloride
Procedure: conventional surgery
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Study of Neoadjuvant Weekly Docetaxel and Mitoxantrone Prior to Prostatectomy in Patients With High Risk Localized Prostate Cancer|
- Number of Participants With 5-year Freedom From Prostate Specific Antigen (PSA) Recurrence. [ Time Frame: Every 3 months after surgery for up to 5 years. ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2000|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Experimental: Docetaxel, Mitoxantrone, Conventional Surgery
Drug: Docetaxel-35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.
Drug: Mitoxantrone-Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks.
Procedure/Surgery: Conventional Surgery- Prostatectomy will be scheduled 2-4 weeks after the last dose of chemotherapy
35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.Drug: mitoxantrone hydrochloride
Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks.Procedure: conventional surgery
Prostatectomy will be scheduled 2 - 4 weeks after the last dose of chemotherapy.
- 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 this regimen.
- 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 this regimen.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00017563
|United States, Oregon|
|OHSU Knight Cancer Institute|
|Portland, Oregon, United States, 97239-3098|
|Portland VA Medical Center|
|Portland, Oregon, United States, 97239|
|Study Chair:||Tomasz M. Beer, MD||OHSU Knight Cancer Institute|