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The purpose of this study is to determine if the combination therapy of Hormone, Paclitaxel and Radiation therapy are effective in treatment of locally advanced prostate cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hormone Suppressors, Paclitaxel & Radiation therapy | Experimental | Hormone Suppressors: Patients may take any of the following combinations for a period of 6 months:
Paclitaxel: 30 mg/m2 twice a week administered as a one hour infusion either Monday & Wednesday or Tuesday & Thursday for eight consecutive weeks will be started within the first week of radiation therapy. Following the first 3 dose levels, the dose of Paclitaxel will be escalated to 35 mg/m2 (dose level IV), 40 mg/m2 (dose level V) & 45 mg/m2 (dose level VI). Radiation Therapy: 5 days a week for 8 weeks to a total dose of 66.6 to 73.8 Gray depending on when patient enter the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hormone Suppressors | Drug |
| ||
| Paclitaxel |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) assessment | The MTD will be the lowest dose at which 2/6 or 2/3 patients experience dose limiting toxicity (DLT) | 8 weeks |
| Number of participants with qualitative and quantitative toxicities | up to 8 months |
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Inclusion Criteria:
In addition patients must also have:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Sanfilippo, MD | NYU Perlmutter 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 |
|---|---|
| D017239 | Paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Drug |
|
|
| Radiation Therapy | Radiation |
|
| 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 |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013812 | Therapeutics |