Status:
COMPLETED
ET 743 (Yondelis) in Men With Advanced Prostate Cancer
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
PharmaMar
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
* 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 thr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00147212
Start Date
June 1 2002
End Date
April 1 2008
Last Update
January 18 2013
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Masachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115