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:~Patients continue on study treatment until disease progression, death, unacceptable toxicity or withdrawal of consent for any reason.
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.