Prostate Cancer
Conditions
Keywords
Advanced Prostate Cancer, Prostate Cancer, Trabectedin, ET 743, Yondelis
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.
Interventions
DRUGET 743
ET-743 administered IV by 24-hr infusion every 3 weeks
Sponsors
Dana-Farber Cancer Institute
PharmaMar
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Men With Advanced Prostate Cancer Treated With Trabectedin Who Have a PSA Response | 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) |
Countries
United States
Participant flow
Recruitment details
Completed
Participants by arm
| Arm | Count |
|---|---|
| Trabectedin Experimental arm treated with trabectedin (ET-743) | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Trabectedin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 25 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants |
| Age Continuous | 65 years STANDARD_DEVIATION 5 |
| Region of Enrollment Spain | 4 participants |
| Region of Enrollment United States | 46 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 10 / 50 |
Outcome results
Primary
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)
Time frame: Participants were followed until disease progression, an average of 6 months
Population: Intent to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trabectedin | The Number of Men With Advanced Prostate Cancer Treated With Trabectedin Who Have a PSA Response | 7 participants |