Phase 2 Study of ET-743 in Subjects With Advanced Ovarian Cancer

This study has been completed.

First Received: December 9, 2002 Last Updated: June 23, 2005 History of Changes

Sponsor:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborator:	PharmaMar
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00050414

Purpose

This is a study to test the safety and effectiveness of an investigational chemotherapy agent in subjects with advanced ovarian 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
Ovarian Cancer	Drug: ET-743	Phase II

Study Type:	Interventional
Study Design:	Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Ecteinascidin 743

U.S. FDA Resources

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 epithelial ovarian cancer
Progression or recurrence during or after platinum containing regimen
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: NCT00050414

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, Kentucky
Norton Hospitals, Inc., Louisville Oncology
Louisville, Kentucky, United States, 40202
United States, Louisiana
Hematology Oncology Specialists
New Orleans, Louisiana, United States, 70115
United States, Massachusetts
Dana Farber Cancer Institute / Mass General Hospital
Boston, Massachusetts, United States, 02114
United States, Oklahoma
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States, 73104
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

No publications provided

Study ID Numbers:	ET743-INT-11
Study First Received:	December 9, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00050414 History of Changes
Health Authority:	United States: Food and Drug Administration

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

ovarian cancer
ovary
cancer

Additional relevant MeSH terms:

Ecteinascidin 743
Ovarian Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases

Pharmacologic Actions
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 09, 2009