Randomized Phase II Study Evaluating the Efficacy of Gemcitabine Versus the Gemcitabine/Docetaxel Combination as Second Line Treatment in Metastatic or Relapsed and Inoperable Uterine or Soft Tissue Leiomyosarcomas
- Compare the anti-tumor activity, in terms of objective response rate, in patients with
metastatic or relapsed, unresectable uterine or soft tissue leiomyosarcoma treated with
gemcitabine with vs without docetaxel as second-line therapy.
- Compare the progression-free survival of patients treated with these regimens.
- Compare the response duration and overall survival of patients treated with these
- Compare the tolerability and dose intensity of these regimens in these patients.
- Determine biological markers with a predictive value for response to these regimens in
OUTLINE: This is a randomized study. Patients are stratified according to location of
leiomyosarcoma (uterine vs soft tissue). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine on days 1, 8, and 15. Treatment repeats every 4
weeks for 2-8 courses.
- Arm II: Patients receive gemcitabine on days 1 and 8 and docetaxel on day 8. Treatment
repeats every 3 weeks for 2-8 courses.
PROJECTED ACCRUAL: A minimum of 80 patients (40 per stratum and treatment arm) will be
accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Anti-tumoral activity (objective response rate)
Florence Duffaud, MD
CHU de la Timone