Trabectedin in Treating Patients With Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus
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|ClinicalTrials.gov Identifier: NCT00379145|
Recruitment Status : Completed
First Posted : September 21, 2006
Results First Posted : December 12, 2017
Last Update Posted : December 12, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Drug: trabectedin||Phase 2|
- 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 (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Evaluation of Trabectedin (Yondelis, R279741) in the Treatment of Advanced, Persistent, or Recurrent Uterine Leiomyosarcomas|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||January 2012|
Trabectedin IV over 24 hours every 3 weeks
- Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 [ 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. ]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 [ Time Frame: Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00379145
|Study Chair:||Bradley J. Monk, MD||Chao Family Comprehensive Cancer Center|