Clinical Trial: Efficacy of Gemcitabine With Pazopanib as Second Line Treatment in Patients With Metastatic or Relapsed Uterine or Soft Tissue Leiomyosarcomas

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Leiomyo

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 Summary:

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.


Sponsor: UNICANCER

Current Primary Outcome: Progression Free Survival [ Time Frame: 9 months ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • disease control rate and overall response rate [ Time Frame: 12 weeks ]
  • Safety of the combination Gemcitabine-Pazopanib [ Time Frame: during the entire trial ]
    The severity of the adverse events and toxicity will be graded according to the NCI CTC-AE v4.0
  • metabolic response by using PET scan [ Time Frame: 6 weeks ]
    First PET scan at baseline and the second one at 6 weeks after the first administration


Original Secondary Outcome: Same as current

Information By: UNICANCER

Dates:
Date Received: August 10, 2011
Date Started: September 2011
Date Completion: September 2017
Last Updated: March 19, 2015
Last Verified: March 2015