XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer (TROPIC)
|Neoplasms Prostatic Neoplasms||Drug: cabazitaxel (XRP6258) (RPR116258) Drug: mitoxantrone Drug: prednisone||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized, Open Label Multi-Center Study of XRP6258 at 25 mg/m^2 in Combination With Prednisone Every 3 Weeks Compared to Mitoxantrone in Combination With Prednisone For The Treatment of Hormone Refractory Metastatic Prostate Cancer Previously Treated With A Taxotere®-Containing Regimen|
- Overall Survival [ Time Frame: 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.
- Time to Progression Free Survival (PFS) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
|Study Start Date:||January 2007|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Active Comparator: Mitoxantrone + Prednisone
Mitoxantrone + Prednisone
12 mg/m^2 administered by intravenous (IV) route over 15-30 minutes on day 1 of each 21-day cycleDrug: prednisone
10 mg daily administered by oral route
Experimental: Cabazitaxel + Prednisone
Cabazitaxel + Prednisone
Drug: cabazitaxel (XRP6258) (RPR116258)
25 mg/m^2 administered by intravenous (IV) route over 1 hour on day 1 of each 21-day cycle
Other Name: JevtanaDrug: prednisone
10 mg daily administered by oral route
Please refer to this study by its ClinicalTrials.gov identifier: NCT00417079
Hide Study Locations
|United States, New Jersey|
|Bridgewater, New Jersey, United States, 08807|
|Buenos Aires, Argentina|
|Sao Paulo, Brazil|
|Laval, Quebec, Canada|
|sanofi-aventis Czech Republic|
|Praha, Czech Republic|
|Korea, Republic of|
|sanofi-aventis South Korea|
|Seoul, Korea, Republic of|
|Moscow, Russian Federation|
|sanofi-aventis South Africa|
|Midrand, South Africa|
|Guildford, Surrey, United Kingdom|