Cabazitaxel Activity in Patients With Advanced AdrenoCortical-Carcinoma Progressing After Previous Chemotherapy Lines
Status:
Recruiting
Trial end date:
2022-01-24
Target enrollment:
Participant gender:
Summary
Adrenocortical cancer (ACC) is a rare aggressive tumor. The treatment of metastatic ACC is
challenging and the current available treatments are mitotane, chemotherapy or the
combination of both. Prognosis in locally advanced inoperable and metastatic ACC patients
still remains poor, the 5-year overall survival being <15%. New treatment strategies are
therefore needed. The taxanes are a class of drugs targeting the microtubules that have shown
to be effective in the treatment of several malignancies but have not been fully developed in
patients with ACC. Cabazitaxel is a new taxoid which promotes the tubulin assembly in vitro
and stabilizes microtubules against cold-induced depolymerization as efficiently as
docetaxel. Cabazitaxel was selected for development based on a better antiproliferative
activity on resistant cell lines than docetaxel. The activity of the drug against several
malignancies is currently tested in ongoing prospective studies, but to our knowledge neither
preclinical nor clinical studies are currently testing cabaztaxel in ACC. This study is aimed
to demonstrate that cabazitaxel is active in ACC, but the drug was never tested before in
this clinical setting. A prospective, non-randomized, multicentre, open label, single arm,
phase II study will be conducted in patients with advanced ACC. The phase II study will be
conducted in 2 different Italian Institutions that are reference centers for ACC.
Phase:
Phase 2
Details
Lead Sponsor:
Azienda Ospedaliera Spedali Civili di Brescia Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia