Clinical Trials Directory

Trials / Completed

CompletedNCT02044354

Patient Preference Between Cabazitaxel and Docetaxel in Metastatic Castrate-resistant Prostate Cancer

A Study of Patient Preference Between Cabazitaxel and Docetaxel in First-line Chemotherapy for Metastatic Castrate-resistant Prostate Cancer

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
195 (actual)
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

Summary

Taxotere is the current standard first-line chemotherapy for mCRPC and may be used as second-line therapy in good responders in first-line (Taxotere rechallenge). Jevtana has demonstrated a survival benefit versus mitoxantrone in patients progressing during or after Taxotere and is now the standard second-line chemotherapy. Taxotere and Jevtana have different toxicity profiles. Many patients who are receiving Jevtana for second-line treatment indicate they prefer this agent over Taxotere with regards to the general tolerance (namely peripheral neuropathy, nail changes, asthenia). This was not expected since Jevtana in post-Taxotere setting was associated with more grade 3-4 adverse events such as febrile neutropenia and diarrhea than Taxotere in first-line setting. The study design of CABA-DOC is similar to that of the PISCES trial which evaluated the patient preference between two standard treatments for first-line metastatic kidney cancer. Despite similar PFS improvements over placebo in phase III trials, results clearly showed that patients preferred pazopanib over sunitinib. A randomized phase III study is currently comparing the efficacy of Taxotere and Jevtana in first-line setting with overall survival as a primary end-point. Assessing patient preference between Jevtana and Taxotere would contribute to further identify differences between these two taxanes and clarify which one of these two taxanes should be used for second-line chemotherapy and perhaps for first-line chemotherapy in the future. Assessing patient preference between the two taxanes might be less biased in the first-line setting where patients have no previous experience with a taxane.

Conditions

Interventions

TypeNameDescription
DRUGTaxotere
DRUGJevtana

Timeline

Start date
2014-05-22
Primary completion
2017-04-13
Completion
2017-12-22
First posted
2014-01-24
Last updated
2026-04-01

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02044354. Inclusion in this directory is not an endorsement.