Clinical Trial: Pazopanib vs. Pazopanib Plus Gemcitabine in Patients With Relapsed or Metastatic Uterine Leiomyosarcomas or Uterine Carcinosarcomas: a Multi-center, Randomized Phase-II Clinical Trial of the NOGGO and AGO - PazoDoble -

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Pazopanib vs. Pazopanib Plus Gemcitabine in Patients With Relapsed or Metastatic Uterine Leiomyosarcomas or Uterine Carcinosarcomas: a Multi-center, Randomized Phase-II Cl

Brief Summary:

Study design:

This study is a prospective, randomized, open-label, multicenter phase II trial in order to determine progression-free survival of patients with refractory or relapsed metastatic uterine leiomyosarcomas or other metastatic uterine tumours.

Indication:

Relapsed or metastatic uterine leiomyosarcomas or carcinosarcomas

Randomization:

Patients with uterine leiomyosarcomas will be randomized in a 1:1-fashion to receive the following therapy

  • Arm A: Pazopanib 800 mg orally once daily plus Gemcitabine 1000 mg/m2 i.v. over 30 min d 1 and d 8 q3w or
  • Arm B: Pazopanib 800 mg orally once daily Patients with uterine carcinosarcomas will be treated according to Arm A.

Planned number of patients:

87 patients with uterine leiomyosarcomas 20 patients with uterine carcinosarcomas

Treatment schedules:

Patients with uterine leiomyosarcomas will be randomized in a 1:1-fashion to receive the following therapy • Arm A (experimental arm / combination arm): Pazopanib 800 mg orally once daily plus Gemcitabine 1000 mg/m2 i.v. over 30 min d 1 and d 8 q3w or

• Arm B (control arm / monotherapy arm): Pazopanib 800 mg orally once daily Patients with uterine carcinosarcomas will be treated according to Arm A.

Planned treatment duration per subject:

Same as current

Current Secondary Outcome:

  • Objective response rate (RECIST v1.1 criteria) [ Time Frame: one year ]
    Time to progression (TTP) of a patient being defined as the time in months from start of the first therapy cycle until PD is observed
  • Objective response rate (RECIST v1.1 criteria) [ Time Frame: one year ]
    Overall survival (OS) calculated from the day of study enrolment until the day of death
  • Objective response rate (RECIST v1.1 criteria) [ Time Frame: one year ]
    Progression-free survival (PFS) calculated from the day of study enrolment until the day of progression/death
  • Safety [ Time Frame: one year ]
    Toxicity and tolerability
  • Quality of life (EORTC QLQ-C30) [ Time Frame: one year ]
    Quality of life (EORTC QLQ-C30)
  • Translational research program [ Time Frame: one year ]
    Translational research within a tumour bank


Original Secondary Outcome: Same as current

Information By: University Medicine Greifswald

Dates:
Date Received: May 5, 2014
Date Started: September 2013
Date Completion: June 2016
Last Updated: July 28, 2014
Last Verified: July 2014