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

Phase 3

• Conditions: Metastatic Castration-resistant Prostate Cancer
• Interventions: Drug: Taxotere; Drug: Jevtana

• Registration Number: NCT02044354
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-22
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-24
• Study Start: 2014-05-22
• Primary Completion: 2017-04-13
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-07
• Last Update Posted: 2017-08-08
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 195

Inclusion Criteria

• 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

Exclusion Criteria

• 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) ;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Patient preference	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.

Trial Locations

Locations (1)

Gustave Roussy; 🇫🇷 Villejuif, Val de Marne, France