Patient Preference Between Cabazitaxel and Docetaxel in Metastatic Castrate-resistant Prostate Cancer (CABA-DOC)
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|ClinicalTrials.gov Identifier: NCT02044354|
Recruitment Status : Unknown
Verified August 2017 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was: Active, not recruiting
First Posted : January 24, 2014
Last Update Posted : August 8, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Castration-resistant Prostate Cancer||Drug: Taxotere Drug: Jevtana||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||195 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of Patient Preference Between Cabazitaxel and Docetaxel in First-line Chemotherapy for Metastatic Castrate-resistant Prostate Cancer|
|Actual Study Start Date :||May 22, 2014|
|Actual Primary Completion Date :||April 13, 2017|
|Estimated Study Completion Date :||April 2018|
Arm Do/Ca : Taxotere 75mg/m2/3w x 4 cycles, followed by Jevtana 25mg/m2/3w x 4 cycles
Arm Ca/Do : Jevtana 25mg/m2/3w x 4 cycles, followed by Taxotere 75mg/m2/3w x 4 cycles
- Patient preference [ Time Frame: Assessed up 21 weeks after randomization ]
Patient preference (Taxotere versus Jevtana) assessed by a single question after completion of the second period of chemotherapy.
Primary outcome measure will be assessed in the intent-to-treat population as defined by all patients having completed the first 4 cycles without progression and having received at least 1 cycle of the second treatment period. Patients having progressed during the first period will discontinue the trial.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02044354
|Villejuif, Val de Marne, France, 94805|
|Study Chair:||Karim Fizazi, MD, PhD||Gustave Roussy, Cancer Campus, Grand Paris|