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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01649635
First received: July 20, 2012
Last updated: October 21, 2014
Last verified: October 2014

July 20, 2012
October 21, 2014
July 2012
January 2014   (final data collection date for primary outcome measure)
Proportion of patients with some episode of neutropenia classified as grade ≥ 3 [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01649635 on ClinicalTrials.gov Archive Site
  • Proportion of patients with episode of neutropenia grade ≥3 [ Time Frame: up to 24 months (every 21 days) ] [ Designated as safety issue: Yes ]
  • Rate of febrile neutropenia [ Time Frame: up to 24 months (every 21 days) ] [ Designated as safety issue: Yes ]
  • Rate of diarrhea grade ≥3 [ Time Frame: up to 24 months (every 21 days) ] [ Designated as safety issue: Yes ]
  • PSA response rate [ Time Frame: up to 24 months (every 21 days) ] [ Designated as safety issue: No ]
  • Circulating Tumor Cells Count (CTC) rate [ Time Frame: Day 42, Day 84, Day 126 and End of Treatment ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Number of patients with adverse events [ Time Frame: up to 24 months (every 21 days) ] [ Designated as safety issue: Yes ]
  • Proportion of patients with episode of neutropenia grade ≥3 [ Time Frame: up to 24 months (every 21 days) ] [ Designated as safety issue: Yes ]
  • Rate of febrile neutropenia grade >=3 [ Time Frame: up to 24 months (every 21 days) ] [ Designated as safety issue: Yes ]
  • Rate of diarrhea grade ≥3 [ Time Frame: up to 24 months (every 21 days) ] [ Designated as safety issue: Yes ]
  • PSA response rate [ Time Frame: up to 24 months (every 21 days) ] [ Designated as safety issue: No ]
  • Circulating Tumor Cells Count (CTC) rate [ Time Frame: Day 42, Day 84, Day 126 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Number of patients with adverse events [ Time Frame: up to 24 months (every 21 days) ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study of Cabazitaxel Combined With Prednisone and Prophylaxis of Neutropenia Complications in the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer
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.

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.

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

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Drug: CABAZITAXEL (XRP6258)
    Pharmaceutical form: solution Route of administration: intravenous
  • Drug: Prednisone
    Pharmaceutical form: tablet Route of administration: oral
  • Drug: Ciprofloxacin
    Pharmaceutical form: tablet Route of administration: oral
  • Drug: G-CSF (Granulocyte colony-stimulating factor)
    Pharmaceutical form: solution Route of administration: subcutaneous
Experimental: 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
Interventions:
  • Drug: CABAZITAXEL (XRP6258)
  • Drug: Prednisone
  • Drug: Ciprofloxacin
  • Drug: G-CSF (Granulocyte colony-stimulating factor)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
45
October 2015
January 2014   (final data collection date for primary outcome measure)

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.

Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01649635
CABAZ_L_06003, U1111-1123-9025
No
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP