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ET 743 (Yondelis) in Men With Advanced Prostate Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00147212
First Posted: September 7, 2005
Last Update Posted: January 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Dana-Farber Cancer Institute
PharmaMar
Information provided by (Responsible Party):
Dror Michaelson, MD, Massachusetts General Hospital
  Purpose
The main purpose of this study is to find out what effects (good or bad) trabectedin (ET743) has on men with advanced prostate carcinoma.

Condition Intervention Phase
Prostate Cancer Drug: ET 743 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Three Hour, Weekly Infusion of ET 743 (Yondelis) in Men With Advanced Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Dror Michaelson, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • The Number of Men With Advanced Prostate Cancer Treated With Trabectedin Who Have a PSA Response [ Time Frame: 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)


Enrollment: 50
Study Start Date: June 2002
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ET-743
Drug: ET 743
ET-743 administered IV by 24-hr infusion every 3 weeks
Other Names:
  • Trabectedin
  • Yondelis

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00147212


Locations
United States, Massachusetts
Masachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
PharmaMar
Investigators
Principal Investigator: Dror Michaelson, MD Massachusetts General Hospital
  More Information

Responsible Party: Dror Michaelson, MD, Assistant Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00147212     History of Changes
Other Study ID Numbers: 02-061
First Submitted: September 2, 2005
First Posted: September 7, 2005
Results First Submitted: March 16, 2012
Results First Posted: January 18, 2013
Last Update Posted: January 18, 2013
Last Verified: December 2012

Keywords provided by Dror Michaelson, MD, Massachusetts General Hospital:
Advanced Prostate Cancer
Prostate Cancer
Trabectedin
ET 743
Yondelis

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Trabectedin
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents