ET 743 (Yondelis) in Men With Advanced Prostate Cancer

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Dana-Farber Cancer Institute; PharmaMar
• Treatments: Trabectedin

Criteria

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