A Phase II Trial of Gemcitabine and Docetaxel in Patients With Unresectable Leiomyosarcoma
- Evaluate the activity of gemcitabine plus docetaxel administered with filgrastim
(G-CSF) support, in terms of disease response, in patients with recurrent or persistent
unresectable leiomyosarcoma or other soft tissue sarcoma.
- Determine the tolerability of this regimen in these patients.
- Correlate response with tumor expression of the apoptosis-regulating proteins bax,
bcl-2, and survivin in these patients.
OUTLINE: Patients are stratified according to prior radiotherapy to the pelvis (yes vs no).
Patients receive gemcitabine IV over 90 minutes on days 1 and 8 followed by docetaxel IV
over 1 hour on day 8 and filgrastim (G-CSF) subcutaneously on days 9-15. Treatment repeats
every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients with a partial response may receive 2 additional courses of therapy.
Patients are followed every 3 months for 1 year or until disease progression.
PROJECTED ACCRUAL: A total of 38-82 patients (19-43 with uterine leiomyosarcoma and 19-39
with other soft tissue sarcoma) will be accrued for this study.
Primary Purpose: Treatment
Robert Maki, MD, PhD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|