Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer
Summary
Primary Objective: * To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m\^2 (Arm A) or 20 mg/m\^2 (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in participants with metastatic castration resistant prostate cancer (mCRPC) and not previously treated with chemotherapy. Secondary Objectives: * To evaluate safety in the 3 treatment arms. * To compare efficacy of cabazitaxel at 20 mg/m\^2 and 25 mg/m\^2 to docetaxel for: * Progression Free Survival (PFS) (RECIST 1.1) * Tumor progression free survival (RECIST 1.1) * Tumor response in participants with measurable disease (RECIST 1.1), * PSA response * PSA-Progression free survival (PSA-PFS). * Pain response in participants with stable pain at baseline * Pain progression free survival * Time to occurrence of any skeletal related events (SRE) * To compare Health-Related Quality of Life (HRQL). * To assess the pharmacokinetics and pharmacogenomics of cabazitaxel.
Timeline
- Start
- 2011-05-05
- Primary completion
- 2015-09
- Completion
- 2018-05
Outcome
Missed primary endpoint
paper C20 and C25 did not demonstrate superiority for OS versus D75 in patients with chemotherapy-naïve mCRPC. PMID 28753384 ↗
registry Docetaxel 75 mg/m^2 vs Cabazitaxel 25 mg/m^2; p = 0.7574; Hazard Ratio (HR) 0.975 (95% CI 0.819 to 1.16) NCT01308567 ↗
registry Docetaxel 75 mg/m^2 vs Cabazitaxel 20 mg/m^2; p = 0.9967; Hazard Ratio (HR) 1.009 (95% CI 0.85 to 1.197) NCT01308567 ↗
Publications
- Carrot A, Oudard S, Colomban O, Fizazi K, Maillet D, Sartor O, Freyer G, You B. Prognostic Value of the Modeled Prostate-Specific Antigen KELIM Confirmation in Metastatic Castration-Resistant Prostate Cancer Treated With Taxanes in FIRSTANA. JCO Clin Cancer Inform. 2024 Feb;8:e2300208. doi: 10.1200/CCI.23.00208.
- Thiery-Vuillemin A, Fizazi K, Sartor O, Oudard S, Bury D, Thangavelu K, Ozatilgan A, Poole EM, Eisenberger M, de Bono J. An analysis of health-related quality of life in the phase III PROSELICA and FIRSTANA studies assessing cabazitaxel in patients with metastatic castration-resistant prostate cancer. ESMO Open. 2021 Apr;6(2):100089. doi: 10.1016/j.esmoop.2021.100089. Epub 2021 Mar 16.
- Mehra N, Dolling D, Sumanasuriya S, Christova R, Pope L, Carreira S, Seed G, Yuan W, Goodall J, Hall E, Flohr P, Boysen G, Bianchini D, Sartor O, Eisenberger MA, Fizazi K, Oudard S, Chadjaa M, Mace S, de Bono JS. Plasma Cell-free DNA Concentration and Outcomes from Taxane Therapy in Metastatic Castration-resistant Prostate Cancer from Two Phase III Trials (FIRSTANA and PROSELICA). Eur Urol. 2018 Sep;74(3):283-291. doi: 10.1016/j.eururo.2018.02.013. Epub 2018 Feb 28.
- Oudard S, Fizazi K, Sengelov L, Daugaard G, Saad F, Hansen S, Hjalm-Eriksson M, Jassem J, Thiery-Vuillemin A, Caffo O, Castellano D, Mainwaring PN, Bernard J, Shen L, Chadjaa M, Sartor O. Cabazitaxel Versus Docetaxel As First-Line Therapy for Patients With Metastatic Castration-Resistant Prostate Cancer: A Randomized Phase III Trial-FIRSTANA. J Clin Oncol. 2017 Oct 1;35(28):3189-3197. doi: 10.1200/JCO.2016.72.1068. Epub 2017 Jul 28.
- de Liano AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.
- Winquist E, Rodrigues G. Open clinical uro-oncology trials in Canada. Can J Urol. 2012 Dec;19(6):6587-91. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cabazitaxel | Other / unclassified | 20 mg/m2 | Intravenous |
| Subject | Cabazitaxel | Other / unclassified | 25 mg/m2 | Intravenous |
| Comparator | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Background | Prednisone | Other / unclassified | 10 mg | Oral |