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Phase 2 Study of ET-743 in Persistent or Recurrent Endometrial Carcinoma
This study has been completed.
Sponsors and Collaborators: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PharmaMar
Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00050440
  Purpose

This is a study is to test the safety and effectiveness of an investigational chemotherapy agent in subjects with persistent or recurrent endometrial cancer. After a subject meets all entry criteria and signs informed consent she will be enrolled in the study. Participants 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.


Condition Intervention Phase
Endometrial Neoplasms
Drug: ET-743
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Ecteinascidin 743
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • Female subjects 18 years of age or older
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00050440

Locations
United States, California
USC, Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90089
United States, Connecticut
Hematology Oncology P.C.
Stamford, Connecticut, United States, 06902
United States, Florida
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Kentucky
Northon Hospitals, Inc., Louisville Oncology
Louisville, Kentucky, United States, 40202
University of Kentucky, Chandler Medical Center
Lexington, Kentucky, United States, 40536
United States, Louisiana
Hematology Oncology Specialists
New Orleans, Louisiana, United States, 70115
Ochsner Cancer Institute
New Orleans, Louisiana, United States, 70121
United States, Maryland
Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
United States, New Jersey
University of Medicine & Dentistry of NJ
Newark, New Jersey, United States
United States, New York
NYU School of Medicine
New York, New York, United States, 10016
United States, Ohio
Cleveland Clinic Foundation, Taussig Cancer Center
Cleveland, Ohio, United States, 44195
United States, Oklahoma
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States, 73104
United States, South Carolina
MUSC, Hollings Cancer Center
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
US Oncology, Dallas
Dallas, Texas, United States, 75204
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PharmaMar
  More Information

Study ID Numbers: ET743-USA-1
Study First Received: December 9, 2002
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00050440  
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
endometrial
cancer
endometrial cancer
endometrial carcinoma

Study placed in the following topic categories:
Ecteinascidin 743
Genital Diseases, Female
Endometrial Neoplasms
Genital Neoplasms, Female
Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms
Endometrial cancer
Recurrence
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009