Spots Global Cancer Trial Database for Trabectedin in Treating Patients With Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus
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Trial Identification
Brief Title: Trabectedin in Treating Patients With Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus
Official Title: A Phase II Evaluation of Trabectedin (Yondelis, R279741) in the Treatment of Advanced, Persistent, or Recurrent Uterine Leiomyosarcomas
Study ID: NCT00379145
Conditions
Interventions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well trabectedin works in treating patients with advanced, persistent, or recurrent leiomyosarcoma of the uterus.
Detailed Description: OBJECTIVES: * Determine the antitumor activity of trabectedin, as measured by frequency and duration of objective response, in patients with advanced, persistent, or recurrent uterine leiomyosarcoma. * Determine the nature and degree of toxicity of this drug in these patients. OUTLINE: This is a nonrandomized, multicenter study. Patients receive trabectedin IV continuously over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve a confirmed complete response may receive at least 2 additional courses. After completion of study treatment, patients are followed every 3 months. PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
USC/Norris Comprehensive Cancer Center and Hospital, El Pueblo De Nuestra Señora De Los Ángeles De Porciúncula, California, United States
Helen and Harry Gray Cancer Center at Hartford Hospital, Hartford, Connecticut, United States
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus, New Britain, Connecticut, United States
Washington Cancer Institute at Washington Hospital Center, Washington, District of Columbia, United States
MBCCOP - Medical College of Georgia Cancer Center, Augusta, Georgia, United States
Central Georgia Gynecologic Oncology, Macon, Georgia, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States
Hinsdale Hematology Oncology Associates, Hinsdale, Illinois, United States
St. Vincent Indianapolis Hospital, Indianapolis, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
St. John's Regional Health Center, Springfield, Missouri, United States
Women's Cancer Center - Lake Mead, Las Vegas, Nevada, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
SUNY Downstate Medical Center, Brooklyn, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States
Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina, United States
Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Case Comprehensive Cancer Center, Cleveland, Ohio, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus, Ohio, United States
Riverside Methodist Hospital Cancer Care, Columbus, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital, Dayton, Ohio, United States
Lake/University Ireland Cancer Center, Mentor, Ohio, United States
Oklahoma University Cancer Institute, Oklahoma City, Oklahoma, United States
Rosenfeld Cancer Center at Abington Memorial Hospital, Abington, Pennsylvania, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin, United States
Contact Details
Name: Bradley J. Monk, MD
Affiliation: Chao Family Comprehensive Cancer Center
Role: STUDY_CHAIR
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