Spots Global Cancer Trial Database for Metronomic Trabectedin, Gemcitabine, and Dacarbazine for Leiomyosarcoma

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Trial Identification

Brief Title: Metronomic Trabectedin, Gemcitabine, and Dacarbazine for Leiomyosarcoma

Official Title: TAGGED: A Phase 2 Study Using Low Dose/Metronomic Trabectedin, Gemcitabine, and Dacarbazine as 2nd/3rd/4th Line Therapy for Advanced Leiomyosarcoma

Study ID: NCT04535271

Conditions

Leiomyosarcoma

Interventions

Trabectedin

Study Description

Brief Summary: This is an open label phase 2 study using metronomic doses of trabectedin, gemcitabine and dacarbazine given intravenously.

Detailed Description: This is an open label phase 2 study using metronomic doses of trabectedin, gemcitabine and dacarbazine given intravenously. A total of 80 patients will receive trabectedin 0.5 mg/m2 as 24 hour continuous intravenous infusion (CIV) on D1 and D8, gemcitabine 250 mg/m2 i.v. on D1 and D8, and dacarbazine 250 mg/m2 i.v. on D1 and D8 (see product information; www.accessdata.fda.gov). Treatment cycles are given every 3 weeks. Patients in this study may continue treatment until significant disease progression or unacceptable toxicity occurs up to one year of therapy. Patients who withdraw or do not complete the first 2 treatment cycles and first follow up CT scan/MRI will be replaced.