Back to resultsStudy of Cabazitaxel Combined With Prednisone and Prophylaxis of Neutropenia Complications in the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer (PROSPECTA)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
CABAZITAXEL (XRP6258)
Prednisone
Ciprofloxacin
G-CSF (Granulocyte colony-stimulating factor)
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
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.
Sites / Locations
- Investigational Site Number 007
- Investigational Site Number 004
- Investigational Site Number 006
- Investigational Site Number 005
- Investigational Site Number 001
- Investigational Site Number 002
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cabazitaxel
Arm Description
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
Outcomes
Primary Outcome Measures
Proportion of patients with some episode of neutropenia classified as grade ≥ 3
Secondary Outcome Measures
Proportion of patients with episode of neutropenia grade ≥3
Rate of febrile neutropenia
Rate of diarrhea grade ≥3
PSA response rate
Circulating Tumor Cells Count (CTC) rate
Changes from baseline in score derived from the Functional assessment of cancer therapy-prostate (FACT-P) and the Trial Outcome Index (TOI)
Number of patients with adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01649635
Brief Title
Study of Cabazitaxel Combined With Prednisone and Prophylaxis of Neutropenia Complications in the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cabazitaxel
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
CABAZITAXEL (XRP6258)
Intervention Description
Pharmaceutical form: solution Route of administration: intravenous
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Pharmaceutical form: tablet Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin
Intervention Description
Pharmaceutical form: tablet Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
G-CSF (Granulocyte colony-stimulating factor)
Intervention Description
Pharmaceutical form: solution Route of administration: subcutaneous
Primary Outcome Measure Information:
Title
Proportion of patients with some episode of neutropenia classified as grade ≥ 3
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Proportion of patients with episode of neutropenia grade ≥3
Time Frame
up to 24 months (every 21 days)
Title
Rate of febrile neutropenia
Time Frame
up to 24 months (every 21 days)
Title
Rate of diarrhea grade ≥3
Time Frame
up to 24 months (every 21 days)
Title
PSA response rate
Time Frame
up to 24 months (every 21 days)
Title
Circulating Tumor Cells Count (CTC) rate
Time Frame
Day 42, Day 84, Day 126 and End of Treatment
Title
Changes from baseline in score derived from the Functional assessment of cancer therapy-prostate (FACT-P) and the Trial Outcome Index (TOI)
Time Frame
up to 24 months (every 21 days)
Title
Number of patients with adverse events
Time Frame
up to 24 months (every 21 days)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 007
City
Centro
ZIP/Postal Code
78020-400
Country
Brazil
Facility Name
Investigational Site Number 004
City
Curitiba
ZIP/Postal Code
81520-060
Country
Brazil
Facility Name
Investigational Site Number 006
City
Lajeado
ZIP/Postal Code
95900-000
Country
Brazil
Facility Name
Investigational Site Number 005
City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Investigational Site Number 001
City
Santo Andre
ZIP/Postal Code
09050-360
Country
Brazil
Facility Name
Investigational Site Number 002
City
São Paulo
ZIP/Postal Code
01321-001
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Study of Cabazitaxel Combined With Prednisone and Prophylaxis of Neutropenia Complications in the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer
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