Phase 2 Study of ET-743 (Trabectedin) in Patients With Persistent or Recurrent Endometrial Carcinoma

January 7, 2013 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

A Phase 2 Study of ET-743 as Second-Line Therapy in Subjects With Persistent or Recurrent Endometrial Carcinoma

The purpose of this is to test the safety and effectiveness of an investigational chemotherapy agent in patients with persistent or recurrent endometrial cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will be enrolled in the study after all study-specific entry criteria are met and informed consent is obtained. Patients will be required to attend regular clinic visits to receive study medication and have their status monitored. They will also be required to have radiologic tumor assessments performed at multiple times throughout the study. A detailed explanation can be provided by the Investigator conducting this study. Trabectedin 1.3 mg/m2 will be given every 21 days to patients intravenously (i.v). over a 3-hour period via a central venous catheter (referred to as a "central line") which is a tube (ie, catheter) placed into a large vein that is used to administer medications. Dexamethasone 4 mg will be given orally (p.o.) the day before trabectedin and dexamethasone 20 mg will be given i.v. 30 minutes before trabectedin. Dexamethasone 4 mg p.o. will be given for 2 days following trabectedin administration.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
  • Netherlands
      • Maastricht, Netherlands
  • Russian Federation
      • Moscow, Russian Federation
      • Moscow N/A, Russian Federation
      • Obninsk N/A, Russian Federation
      • St, Russian Federation
      • St Petersburg, Russian Federation
      • St Petersburg N/A, Russian Federation
  • United States
    • California
      • Los Angeles, California, United States
    • Florida
      • Miami, Florida, United States
    • Kentucky
      • Lexington, Kentucky, United States
    • Maryland
      • Baltimore, Maryland, United States
    • New York
      • New York, New York, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Dallas, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Diagnosis of advanced or metastatic endometrial carcinoma
  • Progressive disease after 1 cytotoxic chemotherapy regimen given for advanced/metastatic disease
  • At least one measureable tumor lesion
  • Adequate bone marrow, hepatic and renal function
  • Performance status ECOG 0 or 1

Exclusion Criteria:

  • Prior exposure to trabectedin
  • Known hypersensitivity to dexamethasone or to any of the components of trabectedin
  • Less than 4 weeks since last radiation therapy or since last dose of hormonal therapy, biological therapy, therapy with any investigational agent, or chemotherapy
  • History of another neoplastic disease unless in remission for more than 5 years
  • Known metastases (spread) of cancer to the central nervous system or other serious illness as specified in the protocol
  • Current pregnancy, lactation, or childbearing potential without adequate method of contraception.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trabectedin
Trabectedin 1.3 mg/m2 administered intravenously every 21 days. Dexamethasone 4 mg administered orally (by mouth) the day before the trabectedin dose, 30 minutes before the trabectedin dose, and for 2 days following the trabectedin dose.
Drug: Trabectedin
Trabectedin 1.3 mg/m2 administered intravenously every 21 days.
Drug: Dexamethasone
Dexamethasone 4 mg administered orally (by mouth) the day before the trabectedin dose, 30 minutes before the trabectedin dose, and for 2 days following the trabectedin dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with objective response
Time Frame: Up to approximately 3 years
Up to approximately 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: Up to approximately 3 years
Up to approximately 3 years
The number of patients with adverse events
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Time to progression (TTP)
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Progression free survival (PFS),
Time Frame: Up to approximately 3 years
Up to approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

PharmaMar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Study Completion (Actual)

July 1, 2004

Study Registration Dates

First Submitted

December 9, 2002

First Submitted That Met QC Criteria

December 9, 2002

First Posted (Estimate)

December 10, 2002

Study Record Updates

Last Update Posted (Estimate)

January 8, 2013

Last Update Submitted That Met QC Criteria

January 7, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR004429
  • ET743-USA-1 (Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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