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

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ClinicalTrials.gov Identifier: NCT00072670
Recruitment Status : Completed
First Posted : November 11, 2003
Last Update Posted : April 8, 2014
Sponsor:
Collaborator:
PharmaMar
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

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Study Type : Interventional  (Clinical Trial)
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 : January 2004
Actual Primary Completion Date : September 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Trabectedin

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




Primary Outcome Measures :
  1. Percentage of Participants Achieving Prostate-Specific Antigen (PSA) Response [ Time Frame: 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 :
  1. Duration of Prostate-Specific Antigen Response [ Time Frame: 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.

  2. Time to disease progression [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00072670


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114-2617
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PharmaMar
Investigators
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Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L.C Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Additional Information:
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Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00072670     History of Changes
Other Study ID Numbers: CR101850
ET-B-025-02
First Posted: November 11, 2003    Key Record Dates
Last Update Posted: April 8, 2014
Last Verified: April 2014

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Prostate cancer
Advanced prostate cancer
Metastatic prostate cancer
Trabectedin
Yondelis
ET-743

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Trabectedin
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents