Patient Preference Between Cabazitaxel and Docetaxel in Metastatic Castrate-resistant Prostate Cancer (CABA-DOC)

Gustave Roussy

Status and phase: Unknown; Phase 3

Conditions: Metastatic Castration-resistant Prostate Cancer

Treatments: Drug: Taxotere; Drug: Jevtana

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02044354

2013/2072 (Other Identifier)

2013-004243-22

Details and patient eligibility

About

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.

Enrollment: 195 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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) ;

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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195 participants in 2 patient groups

Do/Ca

Other group

Description:

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

Treatment:

Drug: Taxotere

Drug: Jevtana

Ca/Do

Other group

Description:

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

Treatment:

Drug: Taxotere

Drug: Jevtana