Safety Study of Combination of Hormone Therapy, Paclitaxel and Radiation Therapy to Treat Prostate Cancer

Study Overview
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Brief Summary
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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

Official Title
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Phase I Study of Bi-weekly Taxol and Definitive Radiation in Androgen Ablated Locally Advanced Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Hormone Suppressors
* Drug: Paclitaxel
* Radiation: Radiation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any one or more of the following characteristics will qualify patient with T2/T3 prostate cancer for eligibility to current study: Biopsy proven prostate cancer with Gleason score > 7 Pathologic staging TXN1 (on MRI or CT) Prostate-specific antigen (PSA) > 10 ng/ml done within a month prior to study entry (the day of first hormonal ablation) and > 10 days after prostate biopsy. In addition patients must also have: Performance status < 2 Hemoglobin > 11 grams per deciliter (g/dL), White blood cell (WBC) > 4000 and platelet count > 100.000/l No evidence of other synchronous primary. Prior malignancies does not exclude if the patient is disease free > 5 years. Prior or concurrent basal cell or non-invasive squamous carcinoma of the skin is eligible and Received hormone therapy with any of the following combination for less than 3 months Lupron / Flutamide Zoladex/ Flutamide Lupron/ Casodex Zoladex/ Casodex Exclusion Criteria: Clinical stage T1N0, PSA < 10, and Gleason score less than 7. Evidence of distant metastasis Previous surgery for prostate cancer (radical prostatectomy). Current treatment with ketoconazole, cimetidine or hormone therapy for more than 3 months prior to inclusion in the protocol for prostate cancer Major medical or psychiatric illness, which in the investigator's opinion may prevent completion of the study and interfere with follow up. Bilirubin > 1.5 Prior chemotherapy is not allowed
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hormone Suppressors, Paclitaxel & Radiation therapy<br>Hormone Suppressors: Patients may take any of the following combinations for a period of 6 months: Lupron / Flutamide Zoladex/ Flutamide Lupron/ Casodex Zoladex/ Casodex 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. | Drug: Hormone Suppressors<br> <br> Drug: Paclitaxel<br> <br> * Other names: Abraxane;Radiation: Radiation Therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |