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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
  Purpose

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.

Condition Intervention Phase
Prostate Cancer
Drug: Cabazitaxel (XRP6258)
Drug: Docetaxel (XRP6976)
Drug: Prednisone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • overall survival [ Time Frame: up to 57 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: up to 57 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1170
Study Start Date: May 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
Cabazitaxel 25 mg/m² intravenously (Day 1) every 3 weeks. Prednisone 10 mg PO daily, from day 1 continuously
Drug: Cabazitaxel (XRP6258)

Pharmaceutical form:solution

Route of administration: intravenous

Drug: Prednisone

Pharmaceutical form:tablet

Route of administration: oral

Experimental: Arm B
Cabazitaxel 20 mg/m² intravenously (Day 1) every 3 weeks. Prednisone 10 mg PO daily, from day 1 continuously
Drug: Cabazitaxel (XRP6258)

Pharmaceutical form:solution

Route of administration: intravenous

Drug: Prednisone

Pharmaceutical form:tablet

Route of administration: oral

Active Comparator: Arm C
Docetaxel 75 mg/m² intravenously (Day 1) every 3 weeks. Prednisone 10 mg PO daily, from day 1 continuously
Drug: Docetaxel (XRP6976)

Pharmaceutical form:solution

Route of administration: intravenous

Drug: Prednisone

Pharmaceutical form:tablet

Route of administration: oral


Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

  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: NCT01308567

  Show 167 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01308567     History of Changes
Other Study ID Numbers: EFC11784, 2010-022064-12, U1111-1117-8356
Study First Received: March 3, 2011
Last Updated: October 17, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Docetaxel
Prednisone
Anti-Inflammatory Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014