Study of Cabazitaxel Combined With Prednisone and Prophylaxis of Neutropenia Complications in the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer

NCT ID: NCT01649635

Last Updated: 2016-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2016-06-30

Brief Summary

Primary Objective:

• To assess effectiveness of prophylactic treatment of hematological complications (grade ≥ 3 neutropenia) resulting from cabazitaxel treatment for 21 days after treatment initiation.

Secondary Objectives:

• PSA response rate;
• Descriptive assessment of CTC (circulating Tumor Cells);
• Rates of grade ≥ 3 neutropenia and febrile neutropenia and grade ≥3 diarrhea over the treatment period;
• Description of the Health Quality of Life of the patients;
• Incidence of adverse events.

Detailed Description

Screening: 15 days Treatment: until disease progression Post-treatment Follow-up: 12 months

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cabazitaxel

25 mg/m2, administered as a 1-hour intravenous infusion, on Day 1 of each cycle, every 21 days Prednisone: 10 mg daily throughout the treatment with cabazitaxel Ciprofloxacin: at a dose of 500 mg for 8 days twice daily (total dose 1.0 g) Granulocyte-Colony Stimulating Factors: maximum dose of 600ug for 7 days or until Absolute Neutrophils Count reaches level ≥ 10.000/mm3

Group Type: EXPERIMENTAL

CABAZITAXEL (XRP6258)

Intervention Type: DRUG

Pharmaceutical form: solution Route of administration: intravenous

Prednisone

Intervention Type: DRUG

Pharmaceutical form: tablet Route of administration: oral

Ciprofloxacin

Intervention Type: DRUG

Pharmaceutical form: tablet Route of administration: oral

G-CSF (Granulocyte colony-stimulating factor)

Intervention Type: DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

Interventions

CABAZITAXEL (XRP6258)

Pharmaceutical form: solution Route of administration: intravenous

Intervention Type: DRUG

Prednisone

Pharmaceutical form: tablet Route of administration: oral

Intervention Type: DRUG

Ciprofloxacin

Pharmaceutical form: tablet Route of administration: oral

Intervention Type: DRUG

G-CSF (Granulocyte colony-stimulating factor)

Pharmaceutical form: solution Route of administration: subcutaneous

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically proven Castration-Resistant Prostate Cancer (stage IV only);
• Prior failure of treatment with docetaxel; o Documentation of metastasis by imaging.
• Performance status 0 or 1;

Exclusion Criteria

• Previous treatment with chemotherapy, except for docetaxel;
• Previous use of abiraterone;
• Inability to maintain treatment with androgen deprivation if no previous history of orchiectomy;
• Presence of any other active malignancy or history of any tumor diagnosed in the last 5 years, except basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the skin, bladder or anal canal (these tumors do not prevent participation if they have been treated, even in the last 5 years);
• Hypersensitivity or known allergy to any of the treatments under study, including history of severe hypersensitivity reaction (≥grade 3) to docetaxel and/or to polysorbate 80 containing drugs
• History of congestive heart failure or myocardial infarction within the last 6 months, or uncontrolled cardiac arrhythmias, angina pectoris or uncontrolled hypertension;
• Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
• Presence of severe comorbidity, which in the opinion of the investigator, puts the patient at risk or impairs compliance to the protocol;
• Known seropositivity for HIV;
• Presence of significant psychiatric or neurological disease, in the investigator's opinion;
• Presence of uncontrolled hypercalcemia;
• Refusal to use appropriate contraception during the study period;
• Participation in any clinical trial in the last 12 months, unless there is benefit to the patient to be justified by the principal investigator
• Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5
• Inadequate organ and bone marrow function

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 007

Centro, , Brazil

Investigational Site Number 004

Curitiba, , Brazil

Investigational Site Number 006

Lajeado, , Brazil

Investigational Site Number 005

Porto Alegre, , Brazil

Investigational Site Number 001

Santo André, , Brazil

Investigational Site Number 002

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

U1111-1123-9025

Identifier Type: OTHER

Identifier Source: secondary_id

CABAZ_L_06003

Identifier Type: -

Identifier Source: org_study_id