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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00050440
Recruitment Status : Completed
First Posted : December 10, 2002
Last Update Posted : January 8, 2013
Sponsor:
Collaborator:
PharmaMar
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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

Condition or disease Intervention/treatment Phase
Endometrial Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Drug: Trabectedin Drug: Dexamethasone Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of ET-743 as Second-Line Therapy in Subjects With Persistent or Recurrent Endometrial Carcinoma
Study Start Date : July 2002
Actual Study Completion Date : July 2004

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with objective response [ Time Frame: Up to approximately 3 years ]

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Up to approximately 3 years ]
  2. The number of patients with adverse events [ Time Frame: Up to approximately 3 years ]
  3. Time to progression (TTP) [ Time Frame: Up to approximately 3 years ]
  4. Progression free survival (PFS), [ Time Frame: Up to approximately 3 years ]

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

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.
Contacts and Locations
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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): NCT00050440


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

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Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00050440    
Obsolete Identifiers: NCT01328314
Other Study ID Numbers: CR004429
ET743-USA-1 ( Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. )
First Posted: December 10, 2002    Key Record Dates
Last Update Posted: January 8, 2013
Last Verified: January 2013
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Endometrial
Cancer
Carcinoma
Trabectedin
Ecteinascidin 743
 ET743
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Endometrial Neoplasms
Urogenital Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Uterine Diseases
Dexamethasone
Trabectedin
Anti-Inflammatory Agents
 Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action