RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving gemcitabine together with docetaxel is more effective than giving gemcitabine alone as second-line therapy in treating uterine or soft tissue leiomyosarcoma. PURPOSE: This randomized phase II trial is studying gemcitabine and docetaxel to see how well they work compared to gemcitabine alone as second-line therapy in treating patients with metastatic or relapsed, unresectable uterine or soft tissue leiomyosarcoma.
OBJECTIVES: Primary * 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. Secondary * Compare the progression-free survival of patients treated with these regimens. * Compare the response duration and overall survival of patients treated with these regimens. * 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 these patients. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Centre Hospitalier Universitaire d'Amiens
Amiens, France
Centre Paul Papin
Angers, France
C.H.G. Beauvais
Beauvais, France
Institut Bergonie
Bordeaux, France
C.H.U. de Brest
Brest, France
Centre Regional Francois Baclesse
Caen, France
Centre Jean Perrin
Clermont-Ferrand, France
Hopital Louis Pasteur
Colmar, France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, France
Centre Oscar Lambret
Lille, France
...and 22 more locations
Anti-tumoral activity (objective response rate)
Time frame: 6 months
Progression-free survival
Time frame: 6 months
Response duration
Time frame: 3 years
Tolerability
Time frame: 3 years
Dose intensity
Time frame: 3 years
Overall survival
Time frame: 3 years
Biological markers
Time frame: 3 years
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