Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments cabazitaxel (xrp6258), docetaxel (xrp6976), prednisone
Phase phase 3
Sponsor Sanofi
Start date May 2011
End date September 2016
Trial size 1170 participants
Trial identifier NCT01308567, 2010-022064-12, EFC11784, U1111-1117-8356

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Cabazitaxel 25 mg/m² intravenously (Day 1) every 3 weeks. Prednisone 10 mg PO daily, from day 1 continuously
cabazitaxel (xrp6258)
Pharmaceutical form:solution Route of administration: intravenous
prednisone
Pharmaceutical form:tablet Route of administration: oral
(Experimental)
Cabazitaxel 20 mg/m² intravenously (Day 1) every 3 weeks. Prednisone 10 mg PO daily, from day 1 continuously
cabazitaxel (xrp6258)
Pharmaceutical form:solution Route of administration: intravenous
prednisone
Pharmaceutical form:tablet Route of administration: oral
(Active Comparator)
Docetaxel 75 mg/m² intravenously (Day 1) every 3 weeks. Prednisone 10 mg PO daily, from day 1 continuously
docetaxel (xrp6976)
Pharmaceutical form:solution Route of administration: intravenous
prednisone
Pharmaceutical form:tablet Route of administration: oral

Primary Outcomes

Measure
overall survival
time frame: up to 57 months

Secondary Outcomes

Measure
Progression Free Survival (PFS)
time frame: up to 57 months

Eligibility Criteria

Male participants at least 18 years old.

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.

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Sanofi.