Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by (Responsible Party):	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT01308567

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:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Prednisone Docetaxel Cabazitaxel

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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:	December 2017
Estimated Primary Completion Date:	December 2017 (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01308567

Contacts

Contact: For site information, send an email with site number to

Contact-Us@sanofi-aventis.com

Show 147 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Clinical Sciences & Operations

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	Sanofi-Aventis
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:	April 13, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Prednisone
Docetaxel

Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2012