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

Prostate Cancer Clinical Trial

— PROSPECTA  

Official title:

A Phase IV, Multicenter, National, Non-comparative, Open-label Study of Cabazitaxel, Combined With Prednisone and Prophylaxis of Neutropenia Complications in the Second-line Treatment of Patients With Metastatic Castration-resistant Prostate Cancer and After Failure of Docetaxel-based Chemotherapy. Descriptive Assessment of the Circulating Tumor Cells in This Context.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01649635
• Other study ID #: CABAZ_L_06003
• Secondary ID: U1111-1123-9025
• Status: Completed
• Phase: Phase 4
• First received: July 20, 2012
• Last updated: July 4, 2016
• Start date: July 2012
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2016
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neutropenia
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• CABAZITAXEL (XRP6258)
Pharmaceutical form: solution Route of administration: intravenous
• Prednisone
Pharmaceutical form: tablet Route of administration: oral
• Ciprofloxacin
Pharmaceutical form: tablet Route of administration: oral
• G-CSF (Granulocyte colony-stimulating factor)
Pharmaceutical form: solution Route of administration: subcutaneous

Locations

Country	Name	City	State
Brazil	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 Andre
Brazil	Investigational Site Number 002	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with some episode of neutropenia classified as grade = 3		21 days	Yes
Secondary	Proportion of patients with episode of neutropenia grade =3		up to 24 months (every 21 days)	Yes
Secondary	Rate of febrile neutropenia		up to 24 months (every 21 days)	Yes
Secondary	Rate of diarrhea grade =3		up to 24 months (every 21 days)	Yes
Secondary	PSA response rate		up to 24 months (every 21 days)	No
Secondary	Circulating Tumor Cells Count (CTC) rate		Day 42, Day 84, Day 126 and End of Treatment	No
Secondary	Changes from baseline in score derived from the Functional assessment of cancer therapy-prostate (FACT-P) and the Trial Outcome Index (TOI)		up to 24 months (every 21 days)	No
Secondary	Number of patients with adverse events		up to 24 months (every 21 days)	Yes