Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma
Leiomyosarcoma, Uterine Neoplasm
About this trial
This is an interventional treatment trial for Leiomyosarcoma focused on measuring early stage, high grade, uterine leiomyosarcoma, adjuvant treatment
Eligibility Criteria
Inclusion Criteria: ≥ 18 years of age high risk uterine LMS, FIGO stage I or II pathology review of LMS high grade and /or mitotic rate greater than or equal to 5 mitoses/10 hpf no longer than 12 weeks from surgical resection of cancer no evidence of residual disease ECOG 0 or 1 ANC ≥ 1,500, hemoglobin ≥ 8.0, platelets ≥100,000 creatinine ≤ 1.5 x institutional upper limits of normal adequate liver function neuropathy (sensory and motor) ≤ CTC grade 1 negative pregnancy test signed consent Exclusion Criteria: patients with other invasive malignancies prior therapy with gemcitabine or docetaxel or doxorubicin hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 women who are breast feeding cardiac ejection fraction <50% prior pelvic irradiation treatment with hormone replacement or anti-hormonal agents or other cytotoxic agents
Sites / Locations
- Washington Cancer Institute/Washington Hospital Center (Medstar)
- H. Lee Moffitt Cancer Center and Research Institute
- Winship Cancer Institute at Emory University
- University of Chicago
- St. Vincent Gynecologic Oncology
- Dana Farber Cancer Institute
- Massachusetts General
- University of Michigan
- Nebraska Methodist Hospital
- Memorial Sloan Kettering Cancer Center
- Pennsylvania Oncology Hematology Associates
- MD Anderson Cancer Center
Arms of the Study
Arm 1
Other
gemcitabine/docetaxel then doxorubicin
Gemcitabine 900 mg/m2 IV over 90 minutes days 1 and 8 Docetaxel 75 mg/m2 IV day 8 (pre-medication dexamethasone 4-8 mg p.o. bid for 3 days, starting 12-24 hours prior to docetaxel). Doxorubicin 60 mg/m2 IVP every 21 days for 4 cycles (recommend use of central venous catheter access).