Sutent Maintenance After Response to Taxotere

Study Overview
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Brief Summary
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The major goal is to determine whether the experimental agent has clinically promising activity that would merit progression to a formal phase III trial. Patients with hormone refractory prostate cancer after docetaxel chemotherapy have limited treatment options and no systemic treatment has been proven to be effective. Because of its action, safety and simple administration SU011248 has potential for effectiveness in this disease setting. Promising activity in this study would provide the necessary proof-of-principle for a larger confirmatory study in this population, and potentially in earlier stages of this common disease.

Official Title
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A Phase II Study of SU011248 for Maintenance Therapy in Hormone Refractory Prostate Cancer After First Line Chemotherapy

Conditions
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Prostate Cancer, Hormone Refractory

Intervention / Treatment
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* Drug: Sunitinib (SU011248)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological or cytological diagnosis of adenocarcinoma of the prostate Metastatic or locally recurrent disease not curable with standard therapy ECOG performance status 0, 1 or 2 Prior single agent docetaxel or docetaxel combination chemotherapy with a documented PSA or imaging response, and no objective evidence of disease progression at study enrolment Exclusion Criteria: Patients with a history of other invasive cancer, except adequately treated non melanoma skin cancer. Patients with known brain metastases. History of allergic reactions attributed to compounds of similar chemical or biologic composition to SU011248. Other serious intercurrent illness or medical condition that might be aggravated by protocol treatment.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sunitinib (SU011248)|SU011248 (study medication) will be given at 50 mg/day as a single agent for 4 consecutive weeks followed by a 2 week rest period to form a complete cycle of 6 weeks. Study medication will be orally self administered once daily without regard to meals beginning on Day 1 of the study. Cycles will be repeated in the absence of unacceptable toxicity or disease progression|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | 180 days without evidence of disease progression would be considered clinically worthy of further investigation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -PSA Response -Toxicity |  | The secondary endpoint of PSA response will also be documented. PSA response is defined as a ≥50% fall in PSA (minimum of 5 µg/L) from baseline maintained for > 3 weeks and without evidence of disease progression otherwise. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sutent