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

• ClinicalTrials.gov Identifier: NCT01649635
• Recruitment Status: Completed
• First Posted: July 25, 2012
• Last Update Posted: July 6, 2016
• Sponsor: Sanofi
• Information provided by (Responsible Party): Sanofi

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.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Drug: CABAZITAXEL (XRP6258); Drug: Prednisone; Drug: Ciprofloxacin; Drug: G-CSF (Granulocyte colony-stimulating factor)	Phase 4

Detailed Description:

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 45 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: July 2012
• Actual Primary Completion Date: January 2014
• Actual Study Completion Date: June 2016

Arms and Interventions

Arm

Intervention/treatment

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

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

Outcome Measures

Primary Outcome Measures :

1. Proportion of patients with some episode of neutropenia classified as grade ≥ 3 [ Time Frame: 21 days ]

Secondary Outcome Measures :

1. Proportion of patients with episode of neutropenia grade ≥3 [ Time Frame: up to 24 months (every 21 days) ]
2. Rate of febrile neutropenia [ Time Frame: up to 24 months (every 21 days) ]
3. Rate of diarrhea grade ≥3 [ Time Frame: up to 24 months (every 21 days) ]
4. PSA response rate [ Time Frame: up to 24 months (every 21 days) ]
5. Circulating Tumor Cells Count (CTC) rate [ Time Frame: Day 42, Day 84, Day 126 and End of Treatment ]
6. 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) ]
7. Number of patients with adverse events [ Time Frame: up to 24 months (every 21 days) ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Brazil

Investigational Site Number 007

Centro, Brazil, 78020-400

Investigational Site Number 004

Curitiba, Brazil, 81520-060

Investigational Site Number 006

Lajeado, Brazil, 95900-000

Investigational Site Number 005

Porto Alegre, Brazil, 90035-903

Investigational Site Number 001

Santo Andre, Brazil, 09050-360

Investigational Site Number 002

São Paulo, Brazil, 01321-001

Sponsors and Collaborators

Sanofi

Investigators

• Study Director: Clinical Sciences & Operations; Sanofi

More Information

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT01649635 History of Changes
• Other Study ID Numbers: CABAZ_L_06003; U1111-1123-9025 ( Other Identifier: UTN )
• First Posted: July 25, 2012
• Last Update Posted: July 6, 2016
• Last Verified: July 2016

Additional relevant MeSH terms:

Prostatic Neoplasms; Neutropenia; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Hematologic Diseases; Ciprofloxacin; Prednisone; Sargramostim; Lenograstim; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Immunologic Factors; Anti-Bacterial Agents; Anti-Infective Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action