Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma

Patients with a diagnosis of early-stage uterine leiomyosarcoma have a 70% chance of relapse or recurrence of their disease. Patients enrolled in this trial will receive 4 cycles of gemcitabine and docetaxel followed by 4 cycles of adriamycin. Following completion of chemotherapy, they will be have repeat imaging at regular intervals to monitor for disease recurrence along with periodic clinical evaluations.

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