A Phase II Evaluation of Trabectedin (Yondelis, R279741) in the Treatment of Advanced, Persistent, or Recurrent Uterine Leiomyosarcomas
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.
Interventional
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Frequency and duration of objective response as measured by RECIST criteria
No
Bradley J. Monk, MD
Study Chair
Chao Family Comprehensive Cancer Center
United States: Federal Government
CDR0000502192
NCT00379145
June 2007
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | New Britain, Connecticut 06050 |
Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
MetroHealth Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44109 |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Washington Cancer Institute at Washington Hospital Center | Washington, District of Columbia 20010 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
SUNY Downstate Medical Center | Brooklyn, New York 11203 |
Lake/University Ireland Cancer Center | Mentor, Ohio 44060 |
St. Vincent Indianapolis Hospital | Indianapolis, Indiana 46260 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
MBCCOP - Medical College of Georgia Cancer Center | Augusta, Georgia 30912-3730 |
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Helen and Harry Gray Cancer Center at Hartford Hospital | Hartford, Connecticut 06102-5037 |
Women's Cancer Center - Lake Mead | Las Vegas, Nevada 89102 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus, Ohio 43210-1240 |
Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Central Georgia Gynecologic Oncology | Macon, Georgia 31201 |