Clinical trial NCT00072670: A Phase 2 Study of Trabectedin (Yondelis) in Adult Male Participants With Advanced Prostate Cancer
Official title: Phase 2 Study of Yondelis in Men With Advanced Prostate Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate cancer
Advanced prostate cancer
Metastatic prostate cancer
Trabectedin
Yondelis
ET-743
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
Collaborators: name: PharmaMar
First posted: 2003-11-11
Enrollment: 59
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate safety and efficacy of trabectedin (ET-743) in adult male participants with advanced metastatic (spread of cancer cells from one part of the body to another) prostate cancer.

Detailed description: This is an open-label (all people know the identity of the intervention), non-randomized, multi-center and Phase 2 study in adult male participants with advanced metastatic prostate cancer. The study consists of 3 parts: Screening (consists of 14 days before study commences on Day -1); Treatment (consists of 4-week dosing cycles wherein trabectedin will be administered as intravenously at a dose of either 0.58 milligram per square meter \[mg/m\^2\] weekly 3-hour infusion, or 1.5 mg/m\^2 or 1.2 mg/m\^2 every three weeks 24-hour infusion); and Follow-up (until survival after the first dose of trabectedin). Participants will discontinue study treatment at disease progression or unacceptable toxicity unless, in the Investigator's opinion, it is deemed that the participants will continue to derive benefit from trabectedin. Efficacy will be evaluated primarily through decline in prostate-specific antigen (substance in blood that is measured to check for prostate cancer) after 72 hours of therapy on Day 1. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate
* Radiographically documented metastatic disease
* Surgical or chemical castration
* Prostate-specific antigen greater than or equal to (\>=) 5 nanogram per milliliter (ng/ml)
* Eastern Cooperative Oncology Group performance status of 0, 1, or 2
* Androgen Independent disease

Exclusion Criteria:

* Treatment with chemotherapy or radiation therapy that was terminated at least 4 weeks before study entry
* Treatment with extensive external beam radiation therapy or radionuclide therapy within 6 weeks of study entry (palliative radiation involving less than 20 percent of bone marrow reserves must have been completed at least 4 weeks before study entry)
* Participant not employing adequate contraception
* Other serious illness or medical conditions as : Uncontrolled congestive heart failure or history of myocardial infection or active angina pectoris within six months preceding registration; active infectious process; chronic active liver disease, including chronic Hepatitis B, chronic Hepatitis C, or cirrhosis

Primary outcomes:
measure: Percentage of Participants Achieving Prostate-Specific Antigen (PSA) Response
timeFrame: Day 1 of each cycle until first documented disease progression up to 4 years
Secondary outcomes:
measure: Duration of Prostate-Specific Antigen Response
timeFrame: Day 1 of each cycle until first documented disease progression up to 4 years
measure: Time to disease progression
timeFrame: Day 1 of each cycle until first documented disease progression up to 4 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L.C Clinical Trial
role: STUDY_DIRECTOR
References: