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: Completed
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