ET 743 (Yondelis) in Men With Advanced Prostate Cancer

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: ET 743

• Registration Number: NCT00147212
• Lead Sponsor: Massachusetts General Hospital

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 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.

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-07
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2012-03-16
• Status Verified: 2012-12
• Results First Submitted QC: 2012-12-11
• Last Update Submitted: 2012-12-11
• Results First Posted: 2013-01-18
• Last Update Posted: 2013-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	ET 743	ET-743

Primary Outcome Measures

Name	Time	Method
The Number of Men With Advanced Prostate Cancer Treated With Trabectedin Who Have a PSA Response	Participants were followed until disease progression, an average of 6 months	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)

Trial Locations

Locations (2)

Masachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States