ET 743 (Yondelis) in Men With Advanced Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00147212
• Other study ID #: 02-061
• Status: Completed
• Phase: Phase 2
• First received: September 2, 2005
• Last updated: December 11, 2012
• Start date: June 2002
• Est. completion date: April 2008

Study information

• Verified date: December 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• ET 743
ET-743 administered IV by 24-hr infusion every 3 weeks

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Masachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Dana-Farber Cancer Institute, PharmaMar

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No