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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00417079
First received: December 28, 2006
Last updated: March 4, 2011
Last verified: March 2011
Results First Received: September 20, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Neoplasms
Prostatic Neoplasms
Interventions: Drug: cabazitaxel (XRP6258) (RPR116258)
Drug: mitoxantrone
Drug: prednisone

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Mitoxantrone + Prednisone mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
Cabazitaxel + Prednisone cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
Total Total of all reporting groups

Baseline Measures
    Mitoxantrone + Prednisone     Cabazitaxel + Prednisone     Total  
Number of Participants  
[units: participants]
  377     378     755  
Age  
[units: years]
Median ( Full Range )
  67.0  
  ( 47 to 89 )  
  68.0  
  ( 46 to 92 )  
  67  
  ( 46 to 92 )  
Gender, Customized  
[units: participants]
     
Male     377     378     755  
Region of Enrollment  
[units: participants]
     
United States     106     97     203  
Taiwan     4     7     11  
Slovakia     1     1     2  
Spain     10     9     19  
Chile     9     12     21  
Russian Federation     6     4     10  
Italy     17     18     35  
India     11     9     20  
France     44     46     90  
Denmark     19     26     45  
South Africa     7     9     16  
Netherlands     8     9     17  
Korea, Republic of     8     7     15  
Finland     4     1     5  
Turkey     17     19     36  
United Kingdom     17     20     37  
Hungary     8     7     15  
Czech Republic     10     12     22  
Mexico     2     3     5  
Canada     16     16     32  
Argentina     7     3     10  
Brazil     7     4     11  
Belgium     16     15     31  
Singapore     6     3     9  
Germany     6     11     17  
Sweden     11     10     21  
Eastern Cooperative Oncology Group (ECOG) Performance Status  
[units: Participants]
     
0 - Fully Active     120     141     261  
1 - Ambulatory, Restricted Activity     224     209     433  
2 - Ambulatory, No Work Activities     33     28     61  
Prostatic Specific Antigen PSA  
[units: ng/mL]
Median ( Full Range )
  127.5  
  ( 2 to 11220 )  
  143.9  
  ( 2 to 7842 )  
  135.00  
  ( 2 to 11220 )  
Measurable disease [1]
[units: Participants]
     
Measurable disease     204     201     405  
Not Measurable disease     173     177     350  
Extent of disease [2]
[units: Participants]
     
Metastatic     356     364     720  
Locoregional Recurrence     20     14     34  
Missing     1     0     1  
Tumor Location: number of sites involved  
[units: Participants]
     
1     134     146     280  
2     117     112     229  
3     78     73     151  
4 or more     43     44     87  
Missing     5     3     8  
[1]

Measurability of the disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria:

Patients with measurable disease have at least one visceral or soft tissue metastatic lesion (including new lesion).

Patient with non-measurable disease have documented rising PSA levels or appearance of new lesion.

[2]

Extent of the disease at screening stage:

  • Metastatic: bone or visceral metastases.
  • Locoregional recurrence includes local recurrent tumor at the primary site, along the draining lymphatic channels, or within the draining lymphatic nodal basin.



  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: From the date of randomization up to 104 weeks (study cut-off) ]

2.  Secondary:   Time to Progression Free Survival (PFS)   [ Time Frame: From the date of randomization up to 104 weeks (study cut-off) ]

3.  Secondary:   Overall Tumor Response   [ Time Frame: From the date of randomization up to 104 weeks (study cut-off) ]

4.  Secondary:   Time to Tumor Progression   [ Time Frame: From the date of randomization up to 104 weeks (study cut-off) ]

5.  Secondary:   Time to Prostatic Specific Antigen (PSA) Progression   [ Time Frame: at screening, day 1 of every treatment cycle, up to 104 weeks (study cut-off) ]

6.  Secondary:   PSA (Prostate-Specific Antigen) Response   [ Time Frame: from baseline up to 104 weeks (study cut-off) ]

7.  Secondary:   Time to Pain Progression   [ Time Frame: from baseline up to 104 weeks (study cut-off) ]

8.  Secondary:   Pain Response   [ Time Frame: from baseline up to 104 weeks (study cut-off) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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