None listed
Conditions
Interventions
THE RANDOMZATION WILL BE PERFORMED BY AN INTERACTIVE VOICE RESPONSE SYSTEM (IVRS). THE RANDOMIZATION BETWEEN THE TWO TREATMENT ARMS WILL BE STRATIFIED USING THE FOLLOWING FACTORS: ECOG PERFORMANCE STA
Sponsors
sanofi-aventis Recherche & Development,
Eligibility
Sex/Gender
Male
Age
18 Years to 82 Years
Inclusion criteria
Inclusion criteria: 101. DIAGNOSIS OF HISTOLOGICALLY OR CYTOLOGICALLY PROVEN PROSTATE ADENOCARCINOMA, THAT IS RESISTANT TO HORMONE THERAPY AND PREVIOUSLY TREATED WITH A DOCETAXEL-CONTAINING REGIMEN. PATIENT MUST HAVE A DOCUMENTED PROGRESSION OF DISEASE DURING OR WITHIN 6 MONTHS AFTER PRIOR HORMONE THERAPY AND DISEASE PROGRESSION DURING OR AFTER DOCETAXEL- CONTAINING THERAPY. 102. PATIENTS MUST HAVE EITHER MEASURABLE OR NON MEASURABLE DISEASE: . PATIENT WITH MEASURABLE DISEASE MUST HAVE DOCUMENTED PROGRESSION OF DISEASE BY RECIST 1.1 CRITERIA. PREVIOUSLY IRRADIATED LESIONS, PRIMARY PROSTATE LESION, AND BONE LESIONS WILL BE CONSIDERED NON MEASURABLE DISEASE. . PATIENTS WITH NON-MEASURABLE DISEASE MUST HAVE DOCUMENTED RISING PSA LEVELS OR APPEARANCE OF NEW LESIONS (≥ 2 NEW LESIONS ON 2 CONSECUTIVE BONE SCANS IF PD DIAGNOSED ON BONE SCAN ONLY). [RISING PSA IS DEFINED AS AT LEAST TWO CONSECUTIVE RISES IN PSA TO BE DOCUMENTED OVER A REFERENCE VALUE (MEASURE 1) TAKEN AT LEAST ONE WEEK APART. THE FIRST RISING PSA (MEASURE 2) SHOULD BE TAKEN AT LEAST 7 DAYS AFTER THE REFERENCE VALUE. A THIRD CONFIRMATORY PSA MEASURE IS REQUIRED (2ND BEYOND THE REFERENCE LEVEL) TO BE GREATER THAN THE SECOND MEASURE AND IT MUST BE OBTAINED AT LEAST 7 DAYS AFTER THE 2ND MEASURE.
Exclusion criteria
Exclusion criteria: EXCLUSION CRITERIA RELATED TO THE STUDY METHODOLOGY E01. PREVIOUS TREATMENT WITH MITOXANTRONE OR CABAZITAXEL. E02. PRIOR ISOTOPE OR RADIOTHERAPY TO ≥ 30% OF THE BONE MARROW. IN CASE OF PRIOR ISOTOPE THERAPY 8 WEEKS (12 WEEKS FOR STRONTIUM-89) MUST HAVE ELAPSED PRIOR TO FIRST STUDY DRUG ADMINISTRATION. E03. 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. E04. PRIOR SURGERY, RADIATION, CHEMOTHERAPY, OR OTHER ANTI-CANCER THERAPY WITHIN 4 WEEKS PRIOR TO ENROLLMENT IN THE STUDY. E05. PRIOR MALIGNANCY. ADEQUATELY TREATED BASAL CELL OR SQUAMOUS CELL SKIN OR SUPERFICIAL (pTIS, pTA AND pT1) BLADDER CANCER ARE ALLOWED, AS WELL AS ANY OTHER CANCER FOR WHICH CHEMOTHERAPY HAS BEEN COMPLETED ≥ 5 YEARS AGO AND FROM WHICH THE PATIENT HAS BEEN DISEASE-FREE FOR ≥ 5 YEARS. E06. PARTICIPATION IN ANOTHER CLINICAL TRIAL AND ANY CONCURRENT TREATMENT WITH ANY INVESTIGATIONAL DRUG WITHIN 30 DAYS PRIOR TO RANDOMIZATION. E07. KNOWN BRAIN OR LEPTOMENINGEAL INVOLVEMENT. E08. OTHER CONCURRENT SERIOUS ILLNESS OR MEDICAL CONDITIONS.
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, France, Germany, Hungary, Korea North, Netherlands, Poland, Romania, Russian Federation, South Africa, Spain, Taiwan, Tunisia, Turkey, United Kindgdom, United States
Contacts
Public ContactKATIA MEZA
SANOFI AVENTIS DEL PERU S.A.
Outcome results
None listed