Study Status: 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 Clinical Trial of the NOGGO and
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
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: