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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA006516 | U.S. NIH Grant/Contract | View source | |
| DFCI-99193 | |||
| NCI-G00-1757 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Rhone-Poulenc Rorer | INDUSTRY |
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients who have stage II or stage III prostate cancer.
OBJECTIVES: I. Determine the pathologic complete response rate to docetaxel in patients with high risk stage II or III prostate cancer. II. Determine the toxicity of this treatment in these patients. III. Correlate clinical measures of response (e.g., symptoms, physical exam, serum PSA, and endorectal MRI) with pathologic response to this treatment in these patients.
OUTLINE: Patients receive docetaxel IV over 30 minutes weekly for 4 weeks. Treatment continues for 2-6 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 19-45 patients will be accrued for this study over 18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docetaxel | Experimental | Docetaxel given via iv at determined dose once a week for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docetaxel | Drug |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate | Wilcoxon Signed Rank Test | 2 Months, 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with mild to moderate toxicity | 6 months |
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Eligibility Criteria:
Histologically confirmed adenocarcinoma of the prostate
Potential candidate for radical prostatectomy
Any of the following:
Clinical stage T3 patients
Serum PSA at least 20 ng/mL
Gleason score 8-10
Clinical T2 disease and either of the following:
CALGB 0-1
WBC greater than 3,000/mm3
Hematocrit greater than 30%
Platelet count greater than 100,000/mm3
SGOT, total bilirubin within normal limits
Signed Informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary-Ellen Taplin, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Beth Israel Deaconess Medical Center |
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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 |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Boston |
| Massachusetts |
| 02115 |
| United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| 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 |