ET 743 (Yondelis) in Men With Advanced Prostate Cancer
|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.|
|ClinicalTrials.gov Identifier: NCT00147212|
Recruitment Status : Completed
First Posted : September 7, 2005
Results First Posted : January 18, 2013
Last Update Posted : January 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: ET 743||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Three Hour, Weekly Infusion of ET 743 (Yondelis) in Men With Advanced Prostate Cancer|
|Study Start Date :||June 2002|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||April 2008|
Drug: ET 743
ET-743 administered IV by 24-hr infusion every 3 weeks
- 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)
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
|United States, Massachusetts|
|Masachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Dror Michaelson, MD||Massachusetts General Hospital|