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

Metastatic Castration-resistant Prostate Cancer Clinical Trial

— CABA-DOC  

Official title:

A Study of Patient Preference Between Cabazitaxel and Docetaxel in First-line Chemotherapy for Metastatic Castrate-resistant Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02044354
• Other study ID #: 2013-004243-22
• Secondary ID: 2013/2072
• Status: Active, not recruiting
• Phase: Phase 3
• First received: January 22, 2014
• Last updated: August 7, 2017
• Start date: May 22, 2014
• Est. completion date: April 2018

Study information

• Verified date: August 2017
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 195
• Est. completion date: April 2018
• Est. primary completion date: April 13, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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) ;

Related Conditions & MeSH terms

• Metastatic Castration-resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Taxotere

• Jevtana

Locations

Country	Name	City	State
France	Gustave Roussy	Villejuif	Val de Marne

Sponsors (2)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris	Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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