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XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer (TROPIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00417079
Recruitment Status : Completed
First Posted : December 29, 2006
Results First Posted : December 23, 2010
Last Update Posted : March 10, 2011
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE December 28, 2006
First Posted Date  ICMJE December 29, 2006
Results First Submitted Date  ICMJE September 20, 2010
Results First Posted Date  ICMJE December 23, 2010
Last Update Posted Date March 10, 2011
Study Start Date  ICMJE January 2007
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2010)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 28, 2006)
The primary outcome measure is overall survival defined as the time interval from the date of randomization to the date of death due to any cause.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2010)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 28, 2006)
  • to be evaluated at screening, day 1 of every treatment cycle, end of study treatment, and in follow-up until documented progression: PSA levels
  • Anti-tumor activity via Computerized Tomography / Magnetic Resonance Imaging (and bone scans, as indicated)
  • Pain via an analgesic consumption score and the Present Pain Index over a one-week period
  • Adverse events; laboratory abnormalities; vital signs
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Neoplasms
  • Prostatic Neoplasms
Intervention  ICMJE
  • 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: Jevtana
  • Drug: mitoxantrone
    12 mg/m^2 administered by intravenous (IV) route over 15-30 minutes on day 1 of each 21-day cycle
  • Drug: prednisone
    10 mg daily administered by oral route
Study Arms  ICMJE
  • Active Comparator: Mitoxantrone + Prednisone
    Mitoxantrone + Prednisone
    Interventions:
    • Drug: mitoxantrone
    • Drug: prednisone
  • Experimental: Cabazitaxel + Prednisone
    Cabazitaxel + Prednisone
    Interventions:
    • Drug: cabazitaxel (XRP6258) (RPR116258)
    • Drug: prednisone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 30, 2010)
755
Original Enrollment  ICMJE
 (submitted: December 28, 2006)
720
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  1. Histologically or cytologically confirmed adenocarcinoma of the prostate that is refractory to hormone therapy and previously treated with a Taxotere®-containing regimen.
  2. Documented progression of disease (demonstrating at least one visceral or soft tissue metastatic lesion, including a new lesion). Patients with non-measurable disease must have documented rising prostate-specific antigen (PSA) levels or appearance of new lesion.
  3. Surgical or hormone-induced castration
  4. Life expectancy > 2 months
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2

Exclusion criteria

  1. Previous treatment with mitoxantrone
  2. Previous treatment with <225 mg/m^2 cumulative dose of Taxotere (or docetaxel)
  3. Prior radiotherapy to ≥ 40% of bone marrow
  4. Surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment in the study
  5. Other prior malignancy, except for adequately treated superficial basal cell skin cancer, or any other cancer from which the patient has been disease-free for less than 5 years
  6. Known brain or leptomeningeal involvement
  7. Other concurrent serious illness or medical conditions
  8. Inadequate organ function evidenced by unacceptable laboratory results

The investigator will evaluate whether there are other reasons why a patient may not participate.

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Belgium,   Brazil,   Canada,   Chile,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Hungary,   India,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Russian Federation,   Singapore,   Slovakia,   South Africa,   Spain,   Sweden,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries Poland,   Uruguay
 
Administrative Information
NCT Number  ICMJE NCT00417079
Other Study ID Numbers  ICMJE EFC6193
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party International Clinical Development Study Director, sanofi-aventis
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Sanofi
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ICD Sanofi
PRS Account Sanofi
Verification Date March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP