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

Phase 3CompletedNCT02044354

Gustave Roussy, Cancer Campus, Grand Paris195 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

195

Conditions

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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) ;

Outcomes

Primary Outcomes

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.

Time frame: Assessed up 21 weeks after randomization