Leiomyosarcoma Clinical Trial
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
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.
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