Efficacy and Safety of Patupilone in Men (≥18 Years) With Metastatic Hormone Refractory Prostate Cancer

Study Overview
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Brief Summary
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The objective of this study is to assess the response of patupilone plus prednisone compared to docetaxel plus prednisone on prostate specific antigen (PSA) in patients with metastatic hormone refractory prostate cancer. Additionally, this study will assess the response on measureable disease and the effects on patient-reported outcomes.

Official Title
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A Randomized Multicenter Phase II Trial of Patupilone (EPO906) Plus Prednisone Versus Docetaxel Plus Prednisone in Patients With Metastatic Hormone Refractory Prostate Cancer

Conditions
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Metastatic Hormone Refractory Prostate Cancer

Intervention / Treatment
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* Drug: Patupilone
* Drug: prednisone
* Drug: docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Must be ≥ 18 years of age Confirmed and documented diagnosis of prostate cancer Confirmed and documented evidence of progression of disease (hormone refractory) Low testosterone levels Chemotherapy-naïve Exclusion criteria: Recent radiation therapy (within 4 weeks) Known brain metastasis Peripheral neuropathy Active diarrhea Significant illnesses such as heart disease, diabetes, or chronic or uncontrolled infections Allergic reactions to patupilone or docetaxel or prednisone or similar compounds Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1: 8 mg/m2 study drug + prednisone<br>Patupilone 8 mg/m2 + prednisone 5 mg bid daily | Drug: Patupilone<br> <br> * Other names: EPO906;Drug: prednisone<br> <br> |
| Experimental: 2: study drug + prednisone days 1 -8<br>Patupilone 10 mg/m2 + prednisone days 1 -8 at 25 mg bid, day 9 at 20 mg bid, day 10 at 15 mg bid, day 11 at 10 mg bid, day 12 - 21 at 5 mg bid | Drug: Patupilone<br> <br> * Other names: EPO906;Drug: prednisone<br> <br> |
| Experimental: 3: Study drug + prednisone days 1 - 4<br>Patupilone 10 mg/m2 + prednisone days 1 - 4 at 5 mg bid, days 5 -12 at 25 mg bid, day 13 at 20 mg bid, day 14 at 15 mg bid, day 15 at 10 mg bid, day 16 - 21 at 5 mg bid | Drug: Patupilone<br> <br> * Other names: EPO906;Drug: prednisone<br> <br> |
| Active Comparator: 4: Docetaxel 75 mg/m2 + prednisone 5 mg bid daily<br>Docetaxel 75 mg/m2 once every 3 weeks + prednisone 5 mg bid daily | Drug: prednisone<br> <br> Drug: docetaxel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antitumor response based on PSA decrease |  | Every 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurable soft tissue response for both regimens |  | Every 6 weeks or every 12 weeks if patient has bone disease for bone scan | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Hormone Refractory, patupilone, docetaxel