ET 743 (Yondelis) in Men With Advanced Prostate Cancer
This study has been completed.
Sponsor:
Massachusetts General Hospital
Collaborators:
Dana-Farber Cancer Institute
PharmaMar
Information provided by (Responsible Party):
Dror Michaelson, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00147212
First received: September 2, 2005
Last updated: December 11, 2012
Last verified: December 2012
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Purpose
The main purpose of this study is to find out what effects (good or bad) trabectedin (ET743) has on men with advanced prostate carcinoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: ET 743 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Three Hour, Weekly Infusion of ET 743 (Yondelis) in Men With Advanced Prostate Cancer |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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)
| Enrollment: | 50 |
| Study Start Date: | June 2002 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
ET-743
|
Drug: ET 743
ET-743 administered IV by 24-hr infusion every 3 weeks
Other Names:
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00147212
Locations
| United States, Massachusetts | |
| Masachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
PharmaMar
Investigators
| Principal Investigator: | Dror Michaelson, MD | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Dror Michaelson, MD, Assistant Professor of Medicine, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00147212 History of Changes |
| Other Study ID Numbers: | 02-061 |
| Study First Received: | September 2, 2005 |
| Results First Received: | March 16, 2012 |
| Last Updated: | December 11, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Massachusetts General Hospital:
|
Advanced Prostate Cancer Prostate Cancer Trabectedin ET 743 Yondelis |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases |
Trabectedin Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013