A Phase 2 Study of Trabectedin (Yondelis) in Adult Male Participants With Advanced Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Phase 2 Study of Yondelis in Men With Advanced Prostate Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00072670
• Other study ID #: CR101850
• Secondary ID: ET-B-025-02
• Status: Completed
• Phase: Phase 2
• First received: November 7, 2003
• Last updated: April 7, 2014
• Start date: January 2004
• Est. completion date: November 2008

Study information

• Verified date: April 2014
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: November 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Trabectedin
Trabectedin will be administered intravenously as either 0.58 milligram per square meter (mg/m^2) weekly as 3-hour infusion or 1.5 mg/m^2 or 1.2 mg/m^2 every three weeks as 24-hour infusion until disease progression or unacceptable toxicity.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	PharmaMar

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Prostate-Specific Antigen (PSA) Response	The PSA response will be evaluated according to National Cancer Institute PSA Working Group criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline after the first dose of study drug, which would be subsequently confirmed by a measurement, that is, at least 4 or more weeks after initial documentation of PSA.	Day 1 of each cycle until first documented disease progression up to 4 years	No
Secondary	Duration of Prostate-Specific Antigen Response	Duration of Prostate-Specific Antigen (PSA) response will be analyzed in all participants for whom a response will be observed. The Duration of a PSA response is the time from a PSA response to PSA progression.	Day 1 of each cycle until first documented disease progression up to 4 years	No
Secondary	Time to disease progression	Time to disease progression is defined as the time period, from initiation of study treatment until documentation of disease progression. If participant will discontinue the study or lost to follow-up without progression or receive further anticancer therapy after study treatment discontinuation in absence of progression, time to progression will be censored at the time of the last PSA evaluation recorded.	Day 1 of each cycle until first documented disease progression up to 4 years	No

External Links

•   Phase 2 Study of Yondelis in Men With Advanced Prostate Carcinoma