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

This study has been completed.
Sponsor:
Collaborator:
PharmaMar
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00050440
First received: December 9, 2002
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female Urogenital Neoplasms
Drug: Trabectedin
Drug: Dexamethasone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

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

Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
  • The number of patients with adverse events [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
  • Time to progression (TTP) [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
  • Progression free survival (PFS), [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: July 2002
Study Completion Date: July 2004
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050440

Locations
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, 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
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.
  More Information

Additional Information:
No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00050440     History of Changes
Obsolete Identifiers: NCT01328314
Other Study ID Numbers: CR004429, ET743-USA-1
Study First Received: December 9, 2002
Last Updated: January 7, 2013
Health Authority: United States: Food and Drug Administration

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:
Carcinoma
Endometrial Neoplasms
Genital Neoplasms, Female
Neoplasms
Urogenital Neoplasms
Uterine Neoplasms
Genital Diseases, Female
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Uterine Diseases
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Molecular Mechanisms of Pharmacological Action
Trabectedin
Alkylating Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on October 30, 2014