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| ID | Type | Description | Link |
|---|---|---|---|
| OHSU-2794 | Other Identifier | OHSU IRB | |
| OHSU-HOR-00037-L | |||
| NCI-G01-1962 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docetaxel, Mitoxantrone, Conventional Surgery | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docetaxel | Drug | 35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
High-risk, as defined by 1 of the following:
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:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Tomasz M. Beer, MD | OHSU Knight Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Portland | Oregon | 97239-3098 | United States | ||
| Portland VA Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Docetaxel and Mitox | Drug: docetaxel 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Docetaxel and Mitox | Drug: docetaxel 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | Every 3 months after surgery for up to 5 years. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Docetaxel and Mitox | Drug: docetaxel 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycemia | Metabolism and nutrition disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tomasz Beer, M.D. | OHSU Knight Cancer Institute | 503-494-1080 | beert@ohsu.edu |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D008942 | Mitoxantrone |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| mitoxantrone hydrochloride | Drug | 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. |
|
| conventional surgery | Procedure | Prostatectomy will be scheduled 2 - 4 weeks after the last dose of chemotherapy. |
|
| Portland |
| Oregon |
| 97239 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 43 |
| 57 |
| 57 |
| 57 |
| Leukopenia | Blood and lymphatic system disorders |
|
| Abdominal Pain | Gastrointestinal disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Dermatology-Skin Toxicity | Skin and subcutaneous tissue disorders |
|
| Alopecia | Skin and subcutaneous tissue disorders |
|
| Anemia | Blood and lymphatic system disorders |
|
| Fatigue | General disorders |
|
| Hypophosphatemia | Blood and lymphatic system disorders |
|
| Hyperlacrimation | Eye disorders |
|
| Onycholysis | Skin and subcutaneous tissue disorders |
|
| Taste Disturbance | General disorders |
|
| Vision | Eye disorders |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |