Phase I/II Study of Neoadjuvant Weekly Docetaxel and Mitoxantrone Prior to Prostatectomy in Patients With High Risk Localized Prostate Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- OHSU Knight Cancer Institute
- Enrollment
- 57
- Locations
- 2
- Primary Endpoint
- Number of Participants With 5-year Freedom From Prostate Specific Antigen (PSA) Recurrence.
Study Overview
Brief Summary
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.
Detailed Description
OBJECTIVES:
- 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)
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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
Intervention: docetaxel (Drug)
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
Intervention: mitoxantrone hydrochloride (Drug)
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
Intervention: conventional surgery (Procedure)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Tom Beer
Principal Investigator
OHSU Knight Cancer Institute