NCT00147212

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
Completed

Started Jun 2002

Typical duration for phase_2 prostate-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

January 18, 2013

Completed
Last Updated

January 18, 2013

Status Verified

December 1, 2012

Enrollment Period

5.8 years

First QC Date

September 2, 2005

Results QC Date

March 16, 2012

Last Update Submit

December 11, 2012

Conditions

Prostate Cancer

Keywords

Advanced Prostate CancerProstate CancerTrabectedinET 743Yondelis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

1

EXPERIMENTAL

ET-743

Drug: ET 743

Interventions

ET 743DRUG

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

Also known as: Trabectedin, Yondelis
1

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Masachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Trabectedin

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

DioxolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
M. Dror Michaelson, MD PhD
Organization
MGH Cancer Center
dmichaelson1@partners.org
6177261594

Study Officials

  • Dror Michaelson, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 7, 2005

Study Start

June 1, 2002

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

January 18, 2013

Results First Posted

January 18, 2013

Record last verified: 2012-12

Locations

US(2)