Neoplasms

All Conditions

Rare Diseases

Leiomyosarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Sarcoma

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Antimetabolites

pazopanib tablets (200mg) per os, 800mg/day continuously gemcitabine IV, 2 injection per cycle

pazopanib + gemcitabine

Patricia Pautier, MD

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.

Efficacy of Gemcitabine With Pazopanib as Second Line Treatment in Patient With Metastatic or Relapsed Uterine

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

PD will not be shared at an individual level, they will be part of the study database including all enrolled patients

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

The severity of the adverse events and toxicity will be graded according to the NCI CTC-AE v4.0

First PET scan at baseline and the second one at 6 weeks after the first administration

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy of Gemcitabine With Pazopanib as Second Line Treatment in Patient With Metastatic or Relapsed Uterine	NCT01442662	Leiomyosarcoma	pazopanib + gem...	18 Years -	UNICANCER
Efficacy of Gemcitabine With Pazopanib as Second Line Treatment in Patient With Metastatic or Relapsed Uterine	NCT01442662	Leiomyosarcoma	pazopanib + gem...	18 Years -	UNICANCER

Spots Global Cancer Trial Database for pazopanib + gemcitabine