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| Name | Class |
|---|---|
| Aventis Pharmaceuticals | INDUSTRY |
| Novartis | INDUSTRY |
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Purpose: The aim of this clinical trail is to evaluate the effectiveness of Zoledronate (Zometa) combined with Estramustine and Docetaxel (Taxotere) in the treatment of patients with hormone-refractory prostate cancer.
Hormone refractory prostate cancer refers to advanced disease in which the patient no longer responds to conventional hormonal treatment. When hormone therapy is no longer successful, chemotherapy is a treatment option. However, current single-agent treatment has shown to have limited benefit. In this clinical trail, investigators are evaluating the effectiveness of Zoledronate(Zometa) combined with Estramustine and Docetaxel (Taxotere) in the treatment of patients with hormone refractory prostate cancer. Zometa is a bisphosphonate, and may reduce or delay skeletal complications caused by bone metastases. Estramustine and Taxotere are chemotherapy drugs that have shown activity in hormone refractory prostate cancer. Eligible patients will be randomized to receive Estramustine and Docetaxel (Taxotere) in combination with Zometa or Zometa given alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zoledronate Alone | Experimental | Zoledronate is given alone for the first cycle. All subsequent cycles consist of Docetaxel (70mg/m^2) given on day 2, Estramustine (280mg) given orally three times per day on days 1-3, and Zoledronate (4mg) given intravenously on day 2. |
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| Docetaxel and Estramustine | Experimental | Docetaxel and Estramustine are given for the first cycle of therapy. All subsequent cycles consist of Docetaxel (70mg/m^2) given on day 2, Estramustine (280mg) given orally three times per day on days 1-3, and Zoledronate (4mg) given intravenously on day 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronic acid | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The Percent Increase/Decrease in Bone Markers from Baseline to Cycle 2 Day 2 (Day 23) of Treatment | To assess and compare the effect of zoledronate and docetaxel/estramustine on markers of bone metabolism in patients with hormone-refractory prostate cancer. | Cycle 2 Day 2 of Treatment (Day 23 of Treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients that Respond to Treatment | A decrease in PSA of greater than or equal to 50%, without evidence of progression in the bones, will be considered as response to treatment. | Post 3 Cycles (63 days) |
| The Number of Toxicities Experienced by Patients |
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All patients must have a histologic diagnosis of hormone-refractory adenocarcinoma of the prostate, and hormone refractory disease must be demonstrated by the appearance of new lesions on bone or CT scan and/or a rising PSA value. (No evidence of brain metastasis or untreated spinal cord compression.)
Patients on total androgen suppression therapy must undergo nonsteroidal antiandrogen withdrawal and demonstrate a rising PSA 4 weeks after withdrawal from flutamide and 6 weeks after withdrawal from bicalutamide.
Patient must not be undergoing current chemotherapy, biologic therapy, other investigational or alternative anti-cancer directed therapy or radiation therapy.
Prior radiation therapy must have completed more than 4 weeks prior to registration.
Patients may not have received prior taxane-based cytotoxic chemotherapy for hormone refractory disease.
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| Name | Affiliation | Role |
|---|---|---|
| David C. Smith, MD | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States |
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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 |
|---|---|
| D000077211 | Zoledronic Acid |
| D004961 | Estramustine |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Estramustine | Drug |
|
| Docetaxel | Drug |
|
| 30 Days Post Treatment |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| 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 |