- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00017563
Combination Chemotherapy Followed by Surgery in Treating Patients With Localized Prostate Cancer
Phase I/II Study of Neoadjuvant Weekly Docetaxel and Mitoxantrone Prior to Prostatectomy in Patients With High Risk 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.
Study Overview
Status
Conditions
Intervention / Treatment
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)
Patients undergo prostatectomy 2-4 weeks after completion of neoadjuvant chemotherapy.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Oregon
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Portland, Oregon, United States, 97239-3098
- OHSU Knight Cancer Institute
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Portland, Oregon, United States, 97239
- Portland VA Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
High-risk, as defined by 1 of the following:
- Stage T2b (palpable bilateral involvement) or surgically resectable T3
- PSA 15 ng/mL or greater
- Gleason grade greater than 4+3 (4+3, 4+4, or 5+any, but not 3+4)
- At least a 50% chance of prostate cancer recurrence within 5 years
- Planned prostatectomy as primary therapy
- No evidence of bone metastases by bone scan
- No evidence of lymph nodes greater than 2 cm on pelvic computed tomography (CT) scan (scan required only if PSA greater than 40 ng/mL)
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Eastern Cooperative Oncology Group(ECOG) 0-2
Life expectancy:
- At least 10 years
Hematopoietic:
- White Blood Cell(WBC) at least 3,000/mm^3
- Neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Conjugated bilirubin no greater than upper limit of normal (ULN)
- Alkaline phosphatase no greater than 4 times ULN
- Alanine transaminase(ALT) no greater than 2 times ULN (1.5 times ULN if alkaline phosphatase greater than 2.5 times ULN)
Renal:
- Not specified
Cardiovascular:
- Ejection fraction greater than 50% by Multiple Gated Acquisition(MUGA)scan
Other:
- No other malignancy within the past 5 years except nonmelanoma skin cancer
- No significant active medical illness that would preclude study therapy
- No peripheral neuropathy grade 2 or greater
- No hypersensitivity to drugs formulated with polysorbate-80
- No significant contraindications to corticosteroids
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior cytotoxic chemotherapy
- No other concurrent cytotoxic chemotherapy
Endocrine therapy:
- No prior or concurrent conventional hormonal therapy
Radiotherapy:
- No prior or concurrent radiotherapy (external beam or brachytherapy)
Surgery:
- See Disease Characteristics
Other:
- No prior or concurrent cryotherapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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.
Prostatectomy will be scheduled 2 - 4 weeks after the last dose of chemotherapy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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.
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Every 3 months after surgery for up to 5 years.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Tomasz M. Beer, MD, OHSU Knight Cancer Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Docetaxel
- Mitoxantrone
Other Study ID Numbers
- CDR0000068719
- OHSU-2794 (Other Identifier: OHSU IRB)
- OHSU-HOR-00037-L
- NCI-G01-1962
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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