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Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer (FIRSTANA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01308567
First received: March 3, 2011
Last updated: October 17, 2014
Last verified: October 2014

March 3, 2011
October 17, 2014
May 2011
March 2015   (final data collection date for primary outcome measure)
overall survival [ Time Frame: up to 57 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01308567 on ClinicalTrials.gov Archive Site
Progression Free Survival (PFS) [ Time Frame: up to 57 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer
Randomized, Open Label, Multi-Center Study Comparing Cabazitaxel at 25 mg/m2 and at 20 mg/m² in Combination With Prednisone Every 3 Weeks to Docetaxel in Combination With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer Not Pretreated With Chemotherapy

Primary Objective:

  • To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m² (Arm A) or 20 mg/m² (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in patients with metastatic castration resistant prostate cancer (mCRPC) and not previously treated with chemotherapy.

Secondary Objectives:

  • To evaluate safety in the 3 treatment arms.
  • To compare efficacy of cabazitaxel at 20 mg/m² and 25 mg/m² to docetaxel for:

    • Progression Free Survival (PFS) (RECIST 1.1)
    • Tumor progression free survival (RECIST 1.1)
    • Tumor response in patients with measurable disease (RECIST 1.1),
    • PSA response
    • PSA-Progression free survival (PSA-PFS).
    • Pain response in patients with stable pain at baseline
    • Pain progression free survival
    • Time to occurrence of any skeletal related events (SRE)
  • To compare Health-Related Quality of Life (HRQL).
  • To assess the pharmacokinetics and pharmacogenomics of cabazitaxel.

Patients will be treated until progressive disease, unacceptable toxicity, or patient's refusal of further study treatment. All patients will be followed when on study treatment and after completion of study treatment during follow up period until death or the study cutoff date, whichever comes first.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Drug: Cabazitaxel (XRP6258)

    Pharmaceutical form:solution

    Route of administration: intravenous

  • Drug: Docetaxel (XRP6976)

    Pharmaceutical form:solution

    Route of administration: intravenous

  • Drug: Prednisone

    Pharmaceutical form:tablet

    Route of administration: oral

  • Experimental: Arm A
    Cabazitaxel 25 mg/m² intravenously (Day 1) every 3 weeks. Prednisone 10 mg PO daily, from day 1 continuously
    Interventions:
    • Drug: Cabazitaxel (XRP6258)
    • Drug: Prednisone
  • Experimental: Arm B
    Cabazitaxel 20 mg/m² intravenously (Day 1) every 3 weeks. Prednisone 10 mg PO daily, from day 1 continuously
    Interventions:
    • Drug: Cabazitaxel (XRP6258)
    • Drug: Prednisone
  • Active Comparator: Arm C
    Docetaxel 75 mg/m² intravenously (Day 1) every 3 weeks. Prednisone 10 mg PO daily, from day 1 continuously
    Interventions:
    • Drug: Docetaxel (XRP6976)
    • Drug: Prednisone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1170
March 2015
March 2015   (final data collection date for primary outcome measure)

Inclusion criteria :

  • I 01. Histologically- or cytologically-confirmed prostate adenocarcinoma.
  • I 02. Metastatic disease.
  • I 03. Progressive disease while receiving hormonal therapy or after surgical castration .

Exclusion criteria:

  • E 01. Prior chemotherapy for prostate cancer,
  • E 02. Less than 28 days elapsed from prior treatment with estramustine, radiotherapy or surgery to the time of randomization. Patients may be on biphosphonates prior to study entry.
  • E 03. Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to >30% of bone marrow.
  • E 04. Adverse events (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy of grade >1(National Cancer Institute Common Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization.
  • E 05. Less than 18 years (or country's legal age of majority if the legal age is >18 years).
  • E 06. Eastern Cooperative Oncology Group (ECOG) performance status >2.
  • E 07. History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis or new evidence of brain or leptomeningeal disease.
  • E 08. Prior malignancy.
  • E 09. Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization.
  • E 10. Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack.
  • E 11. Any of the following within 3 months prior to randomization: treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event.
  • E 12. Acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease requiring antiretroviral treatment.
  • E 13. Any severe acute or chronic medical condition which could impair the ability of the patient to participate to the study or interfere with interpretation of study results, or patient unable to comply with the study procedures.
  • E 14. Absence of signed and dated Institutional Review Board (IRB)-approved patient informed consent form prior to enrollment into the study.
  • E 15. Patients with reproductive potential who do not agree to use accepted and effective method of contraception during the study treatment period.
  • E 16. History of hypersensitivity to docetaxel, or polysorbate 80.
  • E 17. Inadequate organ and bone marrow function
  • E 18. Contraindications to the use of corticosteroid treatment.
  • E 19. Symptomatic peripheral neuropathy grade >2 (National Cancer Institute Common Terminology Criteria [NCI CTCAE] v.4.03).

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
United States,   Australia,   Belarus,   Brazil,   Canada,   China,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Israel,   Italy,   Japan,   Mexico,   Peru,   Poland,   Portugal,   Romania,   Russian Federation,   Spain,   Sweden,   Taiwan,   Turkey,   Ukraine
 
NCT01308567
EFC11784, 2010-022064-12, U1111-1117-8356
Not Provided
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