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A Phase II Study of Three Hour, Weekly Infusion of ET 743 (Yondelis) in Men With Advanced Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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
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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The Number of Men With Advanced Prostate Cancer Treated With Trabectedin Who Have a PSA Response

Outcome 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)

Outcome Time Frame:

Participants were followed until disease progression, an average of 6 months

Safety Issue:

No

Principal Investigator

Dror Michaelson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Food and Drug Administration

Study ID:

02-061

NCT ID:

NCT00147212

Start Date:

June 2002

Completion Date:

April 2008

Related Keywords:

  • Prostate Cancer
  • Advanced Prostate Cancer
  • Prostate Cancer
  • Trabectedin
  • ET 743
  • Yondelis
  • Prostatic Neoplasms

Name

Location
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Masachusetts General Hospital Boston, Massachusetts  02114