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Spots Global Cancer Trial Database for Efficacy of Gemcitabine With Pazopanib as Second Line Treatment in Patient With Metastatic or Relapsed Uterine

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Trial Identification

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

Conditions

Leiomyosarcoma

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Patricia Pautier, MD

Affiliation: Gustave Roussy, Cancer Campus, Grand Paris

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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