ET 743 (Yondelis) in Men With Advanced Prostate Cancer

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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

Key facts

Study ID

NCT00147212

Run by

Massachusetts General Hospital

People needed

50

Starts

2002-06-01

Expected to finish

2008-04-01

Last updated by the study team

2013-01-18

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Masachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.