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Brief Title: Efficacy of Gemcitabine With Pazopanib as Second Line Treatment in Patient With Metastatic or Relapsed Uterine
Official Title: Phase II Multicenter Study to Determine the Efficacy of Gemcitabine With Pazopanib as Second Line Treatment in Patients With Metastatic or Relapsed Uterine or Soft Tissue Leiomyosarcomas
Study ID: NCT01442662
Brief Summary: The aim of this research is to study the activity of pazopanib in second line after anthracyclines in extra uterus and uterine LMS in association with gemcitabine.
Detailed Description: Primary Objectives: To determine the PFS using combination of gemcitabine and pazopanib in patients with metastasis or relapse leiomyosarcoma (uterine or soft tissue)who have already received s first line anthracycline based therapy. Secondary objectives: To determine the disease control rate To determine the response rate To determine toxicities associated with combined gemcitabine and pazopanib To determine correlation between metabolic response and PFS Design: All eligible patients entering the study will receive daily oral pazopanib at 800mg, supplied as 200 mg aqueous film-coated tablets and 2 intravenous gemcitabine every three weeks (8 cycles max). The treatment will continue until the development of unacceptable toxicity or evidence of disease progression or until patient's / investigator's decision of withdrawal.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Institut Bergonié, Bordeaux, , France
Centre François Baclesse, Caen, , France
Centre Jean Perrin, Clermont Ferrand, , France
Centre G.F Leclerc, Dijon, , France
Centre Oscar Lambret, Lille, , France
Centre Léon Bérard, Lyon, , France
Institut Paoli Calmettes, Marseille, , France
CHU Timone, Marseille, , France
Centre Val d'Aurelle Paul Lamarque, Montpellier, , France
Institut de Cancérologie de l'Ouest/Centre René Gauducheau, Nantes Saint Herblain, , France
Centre Antoine Lacassagne, Nice, , France
Institut Curie - Hôpital Claudius Regaud, Paris, , France
Centre Henri Becquerel, Rouen, , France
Institut Curie - Hopital René Huguenin, Saint Cloud, , France
Institut Claudius Regaud, Toulouse, , France
Centre Alexis Vautrin, Vandoeuvre les Nancy, , France
Institut Gustave Roussy, Villejuif, , France
Name: Patricia Pautier, MD
Affiliation: Gustave Roussy, Cancer Campus, Grand Paris
Role: PRINCIPAL_INVESTIGATOR