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
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.
Interventional
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
9 months
No
Patricia Pautier, MD
Principal Investigator
Gustave Roussy Institute
France: Committee for the Protection of Personnes
SARCOME 11/1101
NCT01442662
September 2011
September 2017
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