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

NCT02044354 | Completed Phase 3

• 2 other identifiers: 2013-004243-222013/2072
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief 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

Metastatic Castration-resistant Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Patient preference

  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.

  Assessed up 21 weeks after randomization

Study Arms (2)

Do/Ca

OTHER

Arm Do/Ca : Taxotere 75mg/m2/3w x 4 cycles, followed by Jevtana 25mg/m2/3w x 4 cycles

Drug: Taxotere; Drug: Jevtana

Ca/Do

OTHER

Arm Ca/Do : Jevtana 25mg/m2/3w x 4 cycles, followed by Taxotere 75mg/m2/3w x 4 cycles

Drug: Taxotere; Drug: Jevtana

Interventions

Taxotere DRUG

Ca/Do; Do/Ca

Jevtana DRUG

Ca/Do; Do/Ca

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Affiliated to a social security regimen ;
• Male patients older than 18 years ;
• Histologically confirmed adenocarcinoma of the prostate ;
• Continued androgen deprivation therapy either by LHRH agonists/antagonists or orchidectomy ;
• Serum testosterone \<0.50 ng/ml (1.7 nmol/L) ;
• Progressive disease (PSA progression or radiological progression or clinical progression) ;
• ECOG 0-2 ;
• Information delivered to patient and informed consent form signed by the patient or his legal representative ;
• Adequate organ or bone marrow function as evidenced by:
• Hemoglobin \>/= 10 g/dL
• Absolute neutrophil count \>/=1.5 x 109/L,
• Platelet count \>/=100 x 109/L,
• AST/SGOT and/or ALT/SGPT \</=1.5 x ULN;
• Total bilirubin \</=1.5 x ULN,
• Serum creatinine \</=1.5 x ULN. If creatinine 1.0 - 1.5 xULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance \<60 mL/min should be excluded

You may not qualify if:

• Patients having received an investigational drug and/or prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior enrolment in the study, excepted radiotherapy directed to a single bone lesions which is nonacceptable if within 2 weeks ;
• Prior treatment with Taxotere or Jevtana ;
• Pre-existing symptomatic peripheral neuropathy grade \> 2 (CTCAE V4) ;
• Uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension. History of congestive heart failure (NYHA III or IV) or myocardial infarction within last 6 months is also not allowed ;
• History of severe hypersensitivity reaction (grade ≥3) to polysorbate 80 containing drugs ;
• Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus), active infection including HIV infection, active Hepatitis B or C infection that would preclude participation in the trial ;
• Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) ;

Sponsors & Collaborators

• Sanofi: collaborator
• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Gustave Roussy

Villejuif, Val de Marne, 94805, France

Location

Related Publications (1)

• Baciarello G, Delva R, Gravis G, Tazi Y, Beuzeboc P, Gross-Goupil M, Bompas E, Joly F, Greilsamer C, Hon TNT, Barthelemy P, Culine S, Berdah JF, Deblock M, Ratta R, Flechon A, Cheneau C, Maillard A, Martineau G, Borget I, Fizazi K; Groupe d'Etude des Tumeurs Uro-Genitales (GETUG).. Patient Preference Between Cabazitaxel and Docetaxel for First-line Chemotherapy in Metastatic Castration-resistant Prostate Cancer: The CABADOC Trial. Eur Urol. 2022 Mar;81(3):234-240. doi: 10.1016/j.eururo.2021.10.016. Epub 2021 Nov 14.

  PMID: 34789394 DERIVED

MeSH Terms

Interventions

Docetaxel; cabazitaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Karim Fizazi, MD, PhD

  Gustave Roussy, Cancer Campus, Grand Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: January 24, 2014
• Study Start: May 22, 2014
• Primary Completion: April 13, 2017
• Study Completion: December 22, 2017
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

FR (1)