Trabectedin in Treating Patients With Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus
- Registration Number
- NCT00379145
- Lead Sponsor
- Gynecologic Oncology Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Trabectedin trabectedin Trabectedin IV over 24 hours every 3 weeks
- Primary Outcome Measures
Name Time Method Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression for up to 5 years. RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (32)
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
🇺🇸New Britain, Connecticut, United States
Riverside Methodist Hospital Cancer Care
🇺🇸Columbus, Ohio, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
St. Vincent Indianapolis Hospital
🇺🇸Indianapolis, Indiana, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Washington Cancer Institute at Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Central Georgia Gynecologic Oncology
🇺🇸Macon, Georgia, United States
MBCCOP - Medical College of Georgia Cancer Center
🇺🇸Augusta, Georgia, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States
University of New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Presbyterian Cancer Center at Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Oklahoma University Cancer Institute
🇺🇸Oklahoma City, Oklahoma, United States
Helen and Harry Gray Cancer Center at Hartford Hospital
🇺🇸Hartford, Connecticut, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸El Pueblo De Nuestra Señora De Los Ángeles De Porciúncula, California, United States
Hinsdale Hematology Oncology Associates
🇺🇸Hinsdale, Illinois, 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
Women's Cancer Center - Lake Mead
🇺🇸Las Vegas, Nevada, 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
MetroHealth Cancer Care Center at MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Lake/University Ireland Cancer Center
🇺🇸Mentor, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
SUNY Downstate Medical Center
🇺🇸Brooklyn, New York, United States