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

NCT01649635 | Completed Phase 4

• 2 other identifiers: CABAZ_L_06003U1111-1123-9025
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 6

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with some episode of neutropenia classified as grade ≥ 3

  21 days

Secondary Outcomes (7)

• Proportion of patients with episode of neutropenia grade ≥3

  up to 24 months (every 21 days)

• Rate of febrile neutropenia

  up to 24 months (every 21 days)

• Rate of diarrhea grade ≥3

  up to 24 months (every 21 days)

• PSA response rate

  up to 24 months (every 21 days)

• Circulating Tumor Cells Count (CTC) rate

  Day 42, Day 84, Day 126 and End of Treatment

Study Arms (1)

Cabazitaxel

EXPERIMENTAL

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

Drug: CABAZITAXEL (XRP6258); Drug: Prednisone; Drug: Ciprofloxacin; Drug: G-CSF (Granulocyte colony-stimulating factor)

Interventions

CABAZITAXEL (XRP6258) DRUG

Pharmaceutical form: solution Route of administration: intravenous

Cabazitaxel

Prednisone DRUG

Pharmaceutical form: tablet Route of administration: oral

Cabazitaxel

Ciprofloxacin DRUG

Pharmaceutical form: tablet Route of administration: oral

Cabazitaxel

G-CSF (Granulocyte colony-stimulating factor) DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

Cabazitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (6)

Investigational Site Number 007

Centro, 78020-400, Brazil

Location

Investigational Site Number 004

Curitiba, 81520-060, Brazil

Location

Investigational Site Number 006

Lajeado, 95900-000, Brazil

Location

Investigational Site Number 005

Porto Alegre, 90035-903, Brazil

Location

Investigational Site Number 001

Santo André, 09050-360, Brazil

Location

Investigational Site Number 002

São Paulo, 01321-001, Brazil

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

cabazitaxel; XRP6258; Prednisone; Ciprofloxacin; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2012
• First Posted: July 25, 2012
• Study Start: July 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: June 1, 2016
• Last Updated: July 6, 2016

Record last verified: 2016-07

Locations

BR (6)