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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000365459 | Registry Identifier | PDQ (Physician Data Query) |
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Study was never activated at Fox Chase Cancer Center.
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RATIONALE: Drugs used in chemotherapy, such as paclitaxel, topotecan, and estramustine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving paclitaxel, topotecan, and estramustine together works in treating patients with metastatic hormone therapy-refractory prostate cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15; topotecan IV over 30 minutes on days 2, 9, and 16; and oral estramustine twice daily on days 1 and 2 of course 1 and on days 0-2, 7-9, and 14-16 of all subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 18-38 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| estramustine phosphate sodium | Drug | |||
| paclitaxel | Drug | |||
| topotecan hydrochloride | Drug |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate gland
Failed prior primary hormonal therapy (e.g., estrogen therapy, luteinizing hormone-releasing hormone blocker and flutamide) or bilateral orchiectomy
PSA level ≥ 10 ng/mL if bone metastases only are present (i.e., lacking measurable soft tissue disease)
No elevated serum acid phosphatase or PSA level as the only evidence of disease
No carcinomatous meningitis or brain metastases
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 |
|---|---|---|
| Gary R. Hudes, MD | Fox Chase Cancer Center | Principal Investigator |
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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 |
|---|---|
| D004961 | Estramustine |
| D017239 | Paclitaxel |
| D019772 | Topotecan |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009930 |
| Organic Chemicals |
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |