Clinical trial NCT00147212: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Advanced Prostate Cancer
Prostate Cancer
Trabectedin
ET 743
Yondelis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
name: PharmaMar
First posted: 2005-09-07
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Number of Men With Advanced Prostate Cancer Treated With Trabectedin Who Have a PSA Response
timeFrame: Participants were followed until disease progression, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Masachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Dror Michaelson, MD
role: PRINCIPAL_INVESTIGATOR
References: