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

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)

Overall Status

Completed

CT.gov ID

NCT00072670

Collaborator

PharmaMar (Industry)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Trabectedin	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

59 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase 2 Study of Yondelis in Men With Advanced Prostate Carcinoma

Study Start Date :

Jan 1, 2004

Actual Primary Completion Date :

Sep 1, 2008

Actual Study Completion Date :

Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Trabectedin 0.58 milligram per square meter (mg/m^2) Trabectedin will be administered as 3-hour intravenous infusion at dose of 0.58 mg/m^2 weekly on Day 1, 8 and 15 in 28-day cycle and will be continued until disease progression or unacceptable toxicity.	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. Other Names: ET-743 Yondelis
Experimental: Trabectedin 1.5 mg/m^2 Trabectedin will be administered at dose of 1.5 mg/m^2 as 24-hour infusion every three weeks, and will be continued until disease progression or unacceptable toxicity.	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. Other Names: ET-743 Yondelis
Experimental: Trabectedin 1.2 mg/m^2 Trabectedin will be administered at dose of 1.2 mg/m^2 as 24-hour infusion every three weeks, and will be continued until disease progression or unacceptable toxicity.	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. Other Names: ET-743 Yondelis

Arm

Intervention/Treatment

Experimental: Trabectedin 0.58 milligram per square meter (mg/m^2)

Trabectedin will be administered as 3-hour intravenous infusion at dose of 0.58 mg/m^2 weekly on Day 1, 8 and 15 in 28-day cycle and will be continued until disease progression or unacceptable toxicity.

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.

Other Names:

ET-743

Yondelis

Experimental: Trabectedin 1.5 mg/m^2

Trabectedin will be administered at dose of 1.5 mg/m^2 as 24-hour infusion every three weeks, and will be continued until disease progression or unacceptable toxicity.

Drug: Trabectedin

Other Names:

ET-743

Yondelis

Experimental: Trabectedin 1.2 mg/m^2

Trabectedin will be administered at dose of 1.2 mg/m^2 as 24-hour infusion every three weeks, and will be continued until disease progression or unacceptable toxicity.

Drug: Trabectedin

Other Names:

ET-743

Yondelis

Outcome Measures

Primary Outcome Measures

Percentage of Participants Achieving Prostate-Specific Antigen (PSA) Response [Day 1 of each cycle until first documented disease progression up to 4 years]
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.

Secondary Outcome Measures

Duration of Prostate-Specific Antigen Response [Day 1 of each cycle until first documented disease progression up to 4 years]
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.
Time to disease progression [Day 1 of each cycle until first documented disease progression up to 4 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114-2617

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PharmaMar

Investigators

Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L.C Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.