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
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.
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
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Patricia Pautier, MD
Gustave Roussy Institute
France: Committee for the Protection of Personnes