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ET 743 (Yondelis) in Men With Advanced Prostate Cancer

This study has been completed.
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
PharmaMar
Information provided by (Responsible Party):
Dror Michaelson, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00147212
First received: September 2, 2005
Last updated: December 11, 2012
Last verified: December 2012
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147212

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

No publications provided

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
Study First Received: September 2, 2005
Results First Received: March 16, 2012
Last Updated: December 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Advanced Prostate Cancer
Prostate Cancer
Trabectedin
ET 743
Yondelis

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

ClinicalTrials.gov processed this record on November 25, 2014