A Phase II Study of Three Hour, Weekly Infusion of ET 743 (Yondelis) in Men With Advanced Prostate Cancer
- 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
- 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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Dror Michaelson, MD
Massachusetts General Hospital
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Masachusetts General Hospital||Boston, Massachusetts 02114|