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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
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.
Time frame: CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression for up to 5 years.
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Time frame: Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, 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 D.C., 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
...and 22 more locations