ET 743 (Yondelis) in Men With Advanced Prostate Cancer

NCT ID: NCT00147212

Last Updated: 2013-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-06-30
• Study Completion Date: 2008-04-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

ET-743

Group Type: EXPERIMENTAL

ET 743

Intervention Type: DRUG

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

Interventions

ET 743

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

Intervention Type: DRUG

Other Intervention Names

Trabectedin; Yondelis

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: collaborator

PharmaMar

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dror Michaelson, MD

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dror Michaelson, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Masachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

02-061

Identifier Type: -

Identifier Source: org_study_id