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

Completed · Phase 3

Conditions studied: Prostate Cancer

In brief

Primary Objective: * To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m\^2 (Arm A) or 20 mg/m\^2 (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in participants 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/m\^2 and 25 mg/m\^2 to docetaxel for: * Progression Free Survival (PFS) (RECIST 1.1) * Tumor progression free survival (RECIST 1.1) * Tumor response in participants with measurable disease (RECIST 1.1), * PSA response * PSA-Progression free survival (PSA-PFS). * Pain response in participants 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.

Key facts

Study ID: NCT01308567
Run by: Sanofi
People needed: 1168
Starts: 2011-05-05
Expected to finish: 2018-05-01
Last updated by the study team: 2019-06-05

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

I 01. Histologically- or cytologically-confirmed prostate adenocarcinoma.
I 02. Metastatic disease.
I 03. Progressive disease while receiving hormonal therapy or after surgical castration.
I 04. Effective castration (serum testosterone levels ≤0.50 ng/mL) by orchiectomy and/or luteinizing hormone-releasing hormone (LHRH) agonists or antagonist with or without anti-androgens.

You may not qualify if…

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. Participants 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, New York Heart Association (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 participant to participate to the study or interfere with interpretation of study results, or participants unable to comply with the study procedures.
E 14. Absence of signed and dated Institutional Review Board (IRB)-approved participant informed consent form prior to enrollment into the study.
E 15. Participants with reproductive potential who did 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 was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it is running

Investigational Site Number 840009 — Anaheim, California, United States
Investigational Site Number 840014 — Bakersfield, California, United States
Investigational Site Number 840030 — Sacramento, California, United States
Investigational Site Number 840003 — San Bernardino, California, United States
Investigational Site Number 840012 — San Francisco, California, United States
Investigational Site Number 840019 — Denver, Colorado, United States
Investigational Site Number 840013 — Boca Raton, Florida, United States
Investigational Site Number 840035 — Jacksonville, Florida, United States
Investigational Site Number 840001 — Port Saint Lucie, Florida, United States
Investigational Site Number 840015 — Decatur, Illinois, United States
Investigational Site Number 840018 — Wichita, Kansas, United States
Investigational Site Number 840010 — Paducah, Kentucky, United States
Investigational Site Number 840008 — New Orleans, Louisiana, United States
Investigational Site Number 840006 — Rockville, Maryland, United States
Investigational Site Number 840238 — Boston, Massachusetts, United States
Investigational Site Number 840138 — Boston, Massachusetts, United States
Investigational Site Number 840038 — Brookline, Massachusetts, United States
Investigational Site Number 840005 — Detroit, Michigan, United States
Investigational Site Number 840021 — Saint Louis Park, Minnesota, United States
Investigational Site Number 840016 — Kansas City, Missouri, United States
Investigational Site Number 840020 — Lincoln, Nebraska, United States
Investigational Site Number 840017 — East Orange, New Jersey, United States
Investigational Site Number 840033 — Albuquerque, New Mexico, United States
Investigational Site Number 840036 — Raleigh, North Carolina, United States
Investigational Site Number 840004 — Muscle Shoals, Alabama, United States

Full record on ClinicalTrials.gov

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