Prostate CancerPhase 2NCT00147212
ET 743 (Yondelis) in Men With Advanced Prostate Cancer
A Phase 2 study testing ET 743 in people with Prostate Cancer, run by Massachusetts General Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- ET 743
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2002to Apr 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Masachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase II Study of Three Hour, Weekly Infusion of ET 743 (Yondelis) in Men With Advanced Prostate Cancer
The main purpose of this study is to find out what effects (good or bad) trabectedin (ET743) has on men with advanced prostate carcinoma.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- ET 743
- Keywords
- Advanced Prostate Cancer, Prostate Cancer, Trabectedin, ET 743, Yondelis
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ET 743Drug
Also called Trabectedin, Yondelis
ET-743 administered IV by 24-hr infusion every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ET-743 Receives: Drug: ET 743 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Participants were followed until disease progression, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startJun 2002
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, PharmaMar
- Responsible party
- Principal investigator, Dror Michaelson, MD, Massachusetts General Hospital
- Investigators
- Dror Michaelson, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00147212
- Sponsor's protocol ID
- 02-061
- Status last verified
- Dec 2012
- First submitted
- 2 Sep 2005
- Last updated
- 18 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Three Hour, Weekly Infusion of ET 743 (Yondelis) in Men With Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT00147212
- Acronym / sponsor ID
- 02-061
- Conditions
- Prostate Cancer
- Keywords
- Advanced Prostate Cancer, Prostate Cancer, Trabectedin, ET 743, Yondelis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, PharmaMar
- Study start
- Jun 2002
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 7 Sep 2005 (estimated)
- Results
- Posted 18 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ET 743ET-743 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ET 743Also: Trabectedin, YondelisET-743 administered IV by 24-hr infusion every 3 weeks | Drug | 1 |
Primary outcome
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dror Michaelson, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ET 743 in people with Prostate Cancer, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2013.