Conditions: Sarcoma
Keywords: uterine leiomyosarcoma recurrent uterine sarcoma stage III uterine sarcoma stage IV uterine sarcoma
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 20
Healthy volunteers: no

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.

Arms:
arm 1: Trabectedin IV over 24 hours every 3 weeks

Interventions: intervention 1: trabectedin
Intervention descriptions: intervention 1: None

Protocol document: