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: March 11, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: CABAZITAXEL (XRP6258)
Drug: Prednisone
Drug: Ciprofloxacin
Drug: G-CSF (Granulocyte colony-stimulating factor)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Proportion of patients with some episode of neutropenia classified as grade ≥ 3 [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 45
Study Start Date: July 2012
Estimated Study Completion Date: September 2015
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01649635

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

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01649635     History of Changes
Other Study ID Numbers: CABAZ_L_06003, U1111-1123-9025
Study First Received: July 20, 2012
Last Updated: March 11, 2014
Health Authority: Brazil: National Health Surveillance Agency

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
Prednisone
Ciprofloxacin
Lenograstim
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014