ET 743 (Yondelis) in Men With Advanced Prostate Cancer

Study Overview
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Brief Summary
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The main purpose of this study is to find out what effects (good or bad) trabectedin (ET743) has on men with advanced prostate carcinoma.

Detailed Description
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Treatment with trabectedin will be given once a week for three consecutive weeks with one week of no treatment. This four week period constitutes one cycle. Trabectedin is given as an infusion through a central venous catheter and is administered over 3 hours. On day 1 of each cycle a history, physical exam and blood tests will be performed and trabectedin will be administered. On day 8 and day 15 of each cycle blood work will be performed and trabectedin will be administered. Patients will continue to receive trabectedin as long as there is no disease progression or unacceptable side effects. Scans (CT, MRI or bone) or x-rays may be done while the patient is on the trial at the discretion of the physician.

Official Title
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A Phase II Study of Three Hour, Weekly Infusion of ET 743 (Yondelis) in Men With Advanced Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: ET 743


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed adenocarcinoma of the prostate Radiographically documented metastatic disease Surgical or chemical castration Prostate specific antigen (PSA) > 5 ng/ml Castration resistant prostate cancer (CRPC) One previous taxane-based chemotherapy regimen Eastern Cooperative Group (ECOG) performance status 0,1 or 2 Neutrophil count > 1,500/ul Platelet count > 100,000/ul Serum bilirubin < 1.0 x upper limit normal (ULN) Serum alkaline phosphatase < 1.5 x ULN Asparate aminotransferase/Alanine aminotransferase < 2.5 x ULN Albumin > 2.5 g/dl Serum creatinine < 1.5 x ULN Prior hormonal therapy Exclusion Criteria: Chemotherapy treatment within 4 weeks of study entry Patient not employing adequate contraception Serious illness or medical conditions, specifically: uncontrolled congestive heart failure or history of myocardial infection or active angina pectoris within 6 months; active infectious process; chronic active liver disease, including chronic hepatitis B, C or cirrhosis Current anti-cancer treatment with any non-FDA approved investigational drug

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ET-743 | Drug: ET 743<br>* ET-743 administered IV by 24-hr infusion every 3 weeks<br>* Other names: Yondelis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Men With Advanced Prostate Cancer Treated With Trabectedin Who Have a PSA Response | Prostate specific antigen (PSA) response rate, as defined by the PSA Working Group Criteria (see Bubley et al, J Clin Oncol. 1999 Nov;17(11):3461-7) | Participants were followed until disease progression, an average of 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Prostate Cancer, Prostate Cancer, Trabectedin, ET 743, Yondelis