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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
106
pazopanib tablets (200mg) per os, 800mg/day continuously gemcitabine IV, 2 injection per cycle
Institut Bergonié
Bordeaux, France
Centre François Baclesse
Caen, France
Centre Jean Perrin
Clermont-Ferrand, France
Progression Free Survival
To assess the 9-month Progression Free Survival in Patients With Metastatic or Relapsed Uterine or Soft Tissue Leiomyosarcomas and treated with Gemcitabine and Pazopanib
Time frame: 9 months
disease control rate and overall response rate
Time frame: 12 weeks
Safety of the combination Gemcitabine-Pazopanib
The severity of the adverse events and toxicity will be graded according to the NCI CTC-AE v4.0
Time frame: during the entire trial
metabolic response by using PET scan
First PET scan at baseline and the second one at 6 weeks after the first administration
Time frame: 6 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 7 more locations