Back to resultsET 743 (Yondelis) in Men With Advanced Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ET 743
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Advanced Prostate Cancer, Prostate Cancer, Trabectedin, ET 743, 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
Sites / Locations
- Masachusetts General Hospital
- Dana-Farber Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
ET-743
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT00147212
First Posted
September 2, 2005
Last Updated
December 11, 2012
Sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute, PharmaMar
1. Study Identification
Unique Protocol Identification Number
NCT00147212
Brief Title
ET 743 (Yondelis) in Men With Advanced Prostate Cancer
Official Title
A Phase II Study of Three Hour, Weekly Infusion of ET 743 (Yondelis) in Men With Advanced Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute, PharmaMar
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Advanced Prostate Cancer, Prostate Cancer, Trabectedin, ET 743, Yondelis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
ET-743
Intervention Type
Drug
Intervention Name(s)
ET 743
Other Intervention Name(s)
Trabectedin, Yondelis
Intervention Description
ET-743 administered IV by 24-hr infusion every 3 weeks
Primary Outcome Measure Information:
Title
The Number of Men With Advanced Prostate Cancer Treated With Trabectedin Who Have a PSA Response
Description
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)
Time Frame
Participants were followed until disease progression, an average of 6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dror Michaelson, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Masachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
ET 743 (Yondelis) in Men With Advanced Prostate Cancer
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