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

Sanofi

Status and phase: Completed; Phase 4

Conditions: Prostate Cancer

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01649635

U1111-1123-9025 (Other Identifier)

CABAZ_L_06003

Details and patient eligibility

About

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.

Full description

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

Enrollment: 45 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Cabazitaxel

Experimental group

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

Treatment:

Drug: Ciprofloxacin

Drug: G-CSF (Granulocyte colony-stimulating factor)

Drug: CABAZITAXEL (XRP6258)

Drug: Prednisone