Gemcitabine With or Without Docetaxel as Second-Line Therapy in Treating Patients With Metastatic or Relapsed, Unresectable Uterine or Soft Tissue Leiomyosarcoma
- Registration Number
- NCT00227669
- Lead Sponsor
- UNICANCER
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I: Gemcitabine gemcitabine hydrochloride Gemcitabine at Day 1, Day 8 and Day 15. No treatment at Day 22. 1 cycle = 28 days. Treatment duration: 8 months Arm II: Gemcitabine + Docetaxel gemcitabine hydrochloride Gemcitabine at Day 1 and Day 8. No treatment at Day 15. Docetaxel at Day 8. 1 cycle = 21 days. Treatment duration: 6 months Arm II: Gemcitabine + Docetaxel docetaxel Gemcitabine at Day 1 and Day 8. No treatment at Day 15. Docetaxel at Day 8. 1 cycle = 21 days. Treatment duration: 6 months
- Primary Outcome Measures
Name Time Method Anti-tumoral activity (objective response rate) 6 months
- Secondary Outcome Measures
Name Time Method Progression-free survival 6 months Response duration 3 years Tolerability 3 years Dose intensity 3 years Overall survival 3 years Biological markers 3 years
Trial Locations
- Locations (32)
Centre Paul Papin
🇫🇷Angers, France
Centre Hospitalier Universitaire d'Amiens
🇫🇷Amiens, France
C.H.G. Beauvais
🇫🇷Beauvais, France
Institut Bergonie
🇫🇷Bordeaux, France
C.H.U. de Brest
🇫🇷Brest, France
Centre Regional Francois Baclesse
🇫🇷Caen, France
Hopital Charles Nicolle
🇫🇷Rouen, France
Centre Henri Becquerel
🇫🇷Rouen, France
Centre Rene Huguenin
🇫🇷Saint Cloud, France
Institut Claudius Regaud
🇫🇷Toulouse, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Centre Leon Berard
🇫🇷Lyon, France
Hopital Louis Pasteur
🇫🇷Colmar, France
Centre Oscar Lambret
🇫🇷Lille, France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
🇫🇷Montpellier, France
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
🇫🇷Dijon, France
CHU de la Timone
🇫🇷Marseille, France
Centre Regional Rene Gauducheau
🇫🇷Nantes-Saint Herblain, France
CHR Hotel Dieu
🇫🇷Nantes, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Hopital Edouard Herriot - Lyon
🇫🇷Lyon, France
Hopital Bichat - Claude Bernard
🇫🇷Paris, France
Institut Curie Hopital
🇫🇷Paris, France
Hopital Saint-Louis
🇫🇷Paris, France
CHU Nord
🇫🇷Marseille, France
Centre Eugene Marquis
🇫🇷Rennes, France
Institut de Cancerologie de la Loire
🇫🇷Saint Priest en Jarez, France
Centre Hospitalier Universitaire Bretonneau de Tours
🇫🇷Tours, France
CHR D'Orleans - Hopital de la Source
🇫🇷Orleans, France
CHU Poitiers
🇫🇷Poitiers, France
Hopital Cochin
🇫🇷Paris, France