Gemcitabine With or Without Docetaxel as Second-Line Therapy in Treating Patients With Metastatic or Relapsed, Unresectable Uterine or Soft Tissue Leiomyosarcoma
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Anti-tumoral activity (objective response rate) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Response duration [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Tolerability [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Dose intensity [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Biological markers [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||October 2005|
|Study Completion Date:||August 2012|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Arm I: Gemcitabine
Gemcitabine at Day 1, Day 8 and Day 15. No treatment at Day 22.
1 cycle = 28 days.
Treatment duration: 8 months
|Drug: gemcitabine hydrochloride|
Experimental: Arm II: Gemcitabine + 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
|Drug: docetaxel Drug: gemcitabine hydrochloride|
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00227669
|Centre Hospitalier Universitaire d'Amiens|
|Amiens, France, 80054|
|Centre Paul Papin|
|Angers, France, 49036|
|Beauvais, France, 60021|
|Bordeaux, France, 33076|
|C.H.U. de Brest|
|Brest, France, 29609|
|Centre Regional Francois Baclesse|
|Caen, France, 14076|
|Centre Jean Perrin|
|Clermont-Ferrand, France, 63011|
|Hopital Louis Pasteur|
|Colmar, France, 68024|
|Centre de Lutte Contre le Cancer Georges-Francois Leclerc|
|Dijon, France, 21079|
|Centre Oscar Lambret|
|Lille, France, 59020|
|Centre Leon Berard|
|Lyon, France, 69373|
|Hopital Edouard Herriot - Lyon|
|Lyon, France, 69437|
|CHU de la Timone|
|Marseille, France, 13385|
|Marseille, France, 13915|
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|Centre Regional Rene Gauducheau|
|Nantes-Saint Herblain, France, 44805|
|CHR Hotel Dieu|
|Nantes, France, 44093|
|Centre Antoine Lacassagne|
|Nice, France, 06189|
|CHR D'Orleans - Hopital de la Source|
|Orleans, France, 45067|
|Hopital Bichat - Claude Bernard|
|Paris, France, 75018|
|Institut Curie Hopital|
|Paris, France, 75248|
|Paris, France, 75475|
|Paris, France, 75674|
|Poitiers, France, 86021|
|Centre Eugene Marquis|
|Rennes, France, 35042|
|Hopital Charles Nicolle|
|Rouen, France, 76031|
|Centre Henri Becquerel|
|Rouen, France, 76038|
|Centre Rene Huguenin|
|Saint Cloud, France, 92211|
|Institut de Cancerologie de la Loire|
|Saint Priest en Jarez, France, 42270|
|Institut Claudius Regaud|
|Toulouse, France, 31052|
|Centre Hospitalier Universitaire Bretonneau de Tours|
|Tours, France, 37044|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Study Chair:||Florence Duffaud, MD||CHU de la Timone|