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

NCT02044354

CompletedPhase 3

Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Conditions: Metastatic Castration-resistant Prostate Cancer

Interventions: Taxotere, Jevtana

Countries: France

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.

Eligibility overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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) ;

Locations (1)

Villejuif, Val de Marne, France