XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer
- Conditions
- NeoplasmsProstatic Neoplasms
- Interventions
- Registration Number
- NCT00417079
- Lead Sponsor
- Sanofi
- Brief Summary
This is a randomized, open-label, multi-center study comparing the safety and efficacy of XRP6258 plus prednisone to mitoxantrone plus prednisone in the treatment of hormone refractory metastatic prostate cancer previously treated with a Taxotere®-containing regimen. The primary objective is overall survival. Secondary objectives include progression free survival, overall response rate, prostate-specific antigen (PSA) response/progression, pain response/progression, overall safety, and pharmacokinetics. Patients will be treated until disease progression, death, unacceptable toxicity, or for a maximum of 10 cycles. Patients will have long-term follow-up for a maximum of up to 2 years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 755
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cabazitaxel + Prednisone cabazitaxel (XRP6258) (RPR116258) Cabazitaxel + Prednisone Mitoxantrone + Prednisone mitoxantrone Mitoxantrone + Prednisone Mitoxantrone + Prednisone prednisone Mitoxantrone + Prednisone Cabazitaxel + Prednisone prednisone Cabazitaxel + Prednisone
- Primary Outcome Measures
Name Time Method Overall Survival From the date of randomization up to 104 weeks (study cut-off) Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause.
In the absence of confirmation of death, the survival time was censored at the last date patient was known to be alive or at the cut-off date, whichever had come first.
- Secondary Outcome Measures
Name Time Method Time to Progression Free Survival (PFS) From the date of randomization up to 104 weeks (study cut-off) Progression free survival was defined as a composite endpoint evaluated from the date of randomization to the date of tumor progression, PSA progression, pain progression, or death due to any cause, whichever occurred first
Overall Tumor Response From the date of randomization up to 104 weeks (study cut-off) Tumor Overall Response Rate (ORR) (only in patients with measurable disease):
Objective responses (Complete Response and Partial Response) for measurable disease as assessed by investigators according to RECIST criteria.
Complete Response (CR) is defined as: Disappearance of all target lesions. Partial Response (PR) is defined as: At least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference baseline sum LD.
Confirmation of objective responses will be performed by repeat tumor imaging (CT scans, MRI, bone scans) after the first documentation of response.Time to Tumor Progression From the date of randomization up to 104 weeks (study cut-off) Time to tumor progression is defined as the number of months from randomization until evidence of progressive disease (RECIST)
Time to Prostatic Specific Antigen (PSA) Progression at screening, day 1 of every treatment cycle, up to 104 weeks (study cut-off) In PSA non-responders, progression will be defined as a 25% increase over nadir and increase in the absolute value PSA level by at least 5 ng/ml and confirmed by a second value at least 4 weeks later.
In PSA responders and in patients not evaluable for PSA response at baseline, progression will be defined as a ≥50% increase over nadir, provided that the increase is a minimum of 5 ng/ml and confirmed by a second value at least 1 week later.PSA (Prostate-Specific Antigen) Response from baseline up to 104 weeks (study cut-off) PSA response was defined as a ≥ 50% reduction in serum PSA, determined only for patients with a serum PSA ≥ 20ng/mL at baseline, confirmed by a repeat PSA ≥ 3 weeks later.
Time to Pain Progression from baseline up to 104 weeks (study cut-off) Pain Progression is defined as an increase of ≥1 point in the median Personal Pain Intensity (PPI) from its nadir noted on 2 consecutive 3-week-apart visits or ≥25 % increase in the mean analgesic score compared with the baseline score \& noted on 2 consecutive 3-week-apart visits or requirement for local palliative radiotherapy.
Evaluation of the PPI \& analgesic scores are based on the short-form McGill Pain Questionnaire which consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0=none (best) 1=mild 2=moderate 3=severe (worst) (TOTAL: 0=best 45=worst)Pain Response from baseline up to 104 weeks (study cut-off) Pain Response was defined as a two-point or greater reduction from baseline median Present Pain Intensity (PPI) score without an increased Analgesic Score (AS) or a decrease of ≥50% in the AS without an increase in the PPI score, maintained for at least 3 weeks.
Trial Locations
- Locations (26)
Sanofi-Aventis Hungaria
🇭🇺Budapest, Hungary
sanofi-aventis Finland
🇫🇮Helsinki, Finland
sanofi-aventis India
🇮🇳Mumbai, India
sanofi-aventis Belgium
🇧🇪Diegem, Belgium
sanofi-aventis Czech Republic
🇨🇿Praha, Czech Republic
sanofi-aventis Mexico
🇲🇽Mexico, Mexico
sanofi-aventis Netherlands
🇳🇱Gouda, Netherlands
sanofi-aventis Turkey
🇹🇷Istanbul, Turkey
sanofi-aventis Germany
🇩🇪Berlin, Germany
sanofi-aventis Chile
🇨🇱Santiago, Chile
sanofi-aventis UK
🇬🇧Guildford, Surrey, United Kingdom
sanofi-aventis Brazil
🇧🇷Sao Paulo, Brazil
sanofi-aventis Taiwan
🇨🇳Taipei, Taiwan
sanofi-aventis Singapore
🇸🇬Singapore, Singapore
sanofi-aventis Denmark
🇩🇰Horsholm, Denmark
sanofi-aventis Italy
🇮🇹Milano, Italy
sanofi-aventis South Korea
🇰🇷Seoul, Korea, Republic of
sanofi-aventis Argentina
🇦🇷Buenos Aires, Argentina
sanofi-aventis Spain
🇪🇸Barcelona, Spain
sanofi-aventis US
🇺🇸Bridgewater, New Jersey, United States
sanofi-aventis South Africa
🇿🇦Midrand, South Africa
sanofi-aventis Canada
🇨🇦Laval, Quebec, Canada
sanofi-aventis Sweden
🇸🇪Bromma, Sweden
sanofi-aventis Slovakia
🇸🇰Bratislava, Slovakia
sanofi-aventis France
🇫🇷Paris, France
sanofi-aventis Russia
🇷🇺Moscow, Russian Federation