G0277 A Phase III Randomized Trial of Gemcitabine plus Docetaxel Followed by Doxorubicin versus Observation for Uterus-Limited High-Grade Uterine Leiomyosarcoma (IRCI 001)
1) To determine whether overall survival of patients with uterus-limited high-grade leiomyosarcoma is superior among patients assigned to treatment with adjuvant gemcitabine plus docetaxel followed by doxorubicin compared to patients assigned to observation. 2) To determine whether treatment with adjuvant gemcitabine plus docetaxel followed by doxorubicin improves recurrence-free survival of patients with uterus-limited high-grade leiomyosarcoma compared to observation.
Stage I, high risk uterine leiomyosarcoma limited to the uterus; Normal lab values and good performance status; No evidence of metastatic disease; No prior history of docetaxel, gemcitabine or adriamycin; and No prior whole pelvic radiation.
This treatment will be given in the outpatient treatment area. Patients will be randomized to one of two arms. Arm I: Gemcitabine 900 mg/m2 IV days 1 and 8, Docetaxel 75 mg/m2 IV day 8. Every 21 days for 4 cycles. CT/MRI imaging to confirm disease-free after the 4 cycles, followed by Doxorubicin 60 mg/m2 IV every 21 days for 4 cycles. Arm II: Observation only.
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