Trabectedin in Treating Patients With Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Evaluation of Trabectedin (Yondelis, R279741) in the Treatment of Advanced, Persistent, or Recurrent Uterine Leiomyosarcomas|
- Frequency and duration of objective response as measured by RECIST criteria [ Time Frame: every 21 days during treatment until disease progression or death ] [ Designated as safety issue: No ]
- Frequency and severity of adverse effects as measured by CTCAE v3.0 [ Time Frame: every 21 days during treatment until disease progression or death ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2007|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Trabectedin IV over 24 hours every 3 weeks
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00379145
Show 32 Study Locations
|Study Chair:||Bradley J. Monk, MD||Chao Family Comprehensive Cancer Center|