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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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Multicenter study: 146 actives sites from 26 countries in Europe, USA, South America and Asia Pacific region. Study initiation date: January 2nd, 2007; study completion date/study cut off date: September 25th, 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

165 patients signed informed consent but were not randomized and considered as screen failure.

Intention to Treat Population (ITT or randomized patients): 755 patients (377 mitoxantrone, 378 cabazitaxel).

Safety population (treated patients): 742 patients (371 mitoxantrone, 371 cabazitaxel) (Patients not treated: 6 mitoxantrone, 7 cabazitaxel).


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

Participant Flow:   Overall Study
    Mitoxantrone + Prednisone   Cabazitaxel + Prednisone
STARTED   377 [1]   378 [1] 
COMPLETED   46 [1]   105 [1] 
NOT COMPLETED   331   273 
Disease progression                267                180 
Adverse Event                32                67 
Non-compliance to protocol                0                1 
Lost to Follow-up                2                0 
Withdrawal by Subject                17                8 
Not treated                6                7 
Screened failure                2                1 
Investigator's decision                1                4 
Non-confirmed Disease progression                1                1 
Clinical deterioration                1                0 
Screening error                2                1 
Withdrawal by subject's family                0                1 
Patient unable to come to the clinic                0                1 
abnormal liver function tests                0                1 
[1] Randomized patients



  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.
No text entered.

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 
Overall Participants Analyzed 
[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 
[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.

Extent of disease [1] 
[Units: Participants]
     
Metastatic   356   364   720 
Locoregional Recurrence   20   14   34 
Missing   1   0   1 
[1]

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.
Tumor Location: number of sites involved 
[Units: Participants]
     
 134   146   280 
 117   112   229 
 78   73   151 
4 or more   43   44   87 
Missing   5   3   8 


  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
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Time Frame Adverse events are collected from the time to the first patient signed an informed consent form until 30 days after the administration of the last cycle of the study treatment to the last patient (i.e. 104 weeks).
Additional Description The safety analyses are performed on the safety population which includes all randomized patients who received at least part of one dose of the study drug.

Frequency Threshold
Threshold above which other adverse events are reported   5  

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

Other Adverse Events
    Mitoxantrone + Prednisone   Cabazitaxel + Prednisone
Total, other (not including serious) adverse events     
# participants affected / at risk   323/371 (87.06%)   350/371 (94.34%) 
Blood and lymphatic system disorders     
Neutropenia * 1     
# participants affected / at risk   38/371 (10.24%)   66/371 (17.79%) 
Anaemia * 1     
# participants affected / at risk   18/371 (4.85%)   38/371 (10.24%) 
Gastrointestinal disorders     
Diarrhoea * 1     
# participants affected / at risk   39/371 (10.51%)   170/371 (45.82%) 
Nausea * 1     
# participants affected / at risk   84/371 (22.64%)   127/371 (34.23%) 
Vomiting * 1     
# participants affected / at risk   36/371 (9.70%)   80/371 (21.56%) 
Constipation * 1     
# participants affected / at risk   56/371 (15.09%)   73/371 (19.68%) 
Abdominal pain * 1     
# participants affected / at risk   13/371 (3.50%)   38/371 (10.24%) 
Dyspepsia * 1     
# participants affected / at risk   6/371 (1.62%)   25/371 (6.74%) 
Abdominal pain upper * 1     
# participants affected / at risk   5/371 (1.35%)   20/371 (5.39%) 
General disorders     
Fatigue * 1     
# participants affected / at risk   102/371 (27.49%)   136/371 (36.66%) 
Asthenia * 1     
# participants affected / at risk   46/371 (12.40%)   76/371 (20.49%) 
Pyrexia * 1     
# participants affected / at risk   22/371 (5.93%)   40/371 (10.78%) 
Oedema peripheral * 1     
# participants affected / at risk   34/371 (9.16%)   34/371 (9.16%) 
Mucosal inflammation * 1     
# participants affected / at risk   10/371 (2.70%)   22/371 (5.93%) 
Pain * 1     
# participants affected / at risk   18/371 (4.85%)   19/371 (5.12%) 
Infections and infestations     
Urinary tract infection * 1     
# participants affected / at risk   9/371 (2.43%)   24/371 (6.47%) 
Investigations     
Weight decreased * 1     
# participants affected / at risk   28/371 (7.55%)   32/371 (8.63%) 
Metabolism and nutrition disorders     
Anorexia * 1     
# participants affected / at risk   39/371 (10.51%)   59/371 (15.90%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1     
# participants affected / at risk   41/371 (11.05%)   58/371 (15.63%) 
Arthralgia * 1     
# participants affected / at risk   31/371 (8.36%)   39/371 (10.51%) 
Pain in extremity * 1     
# participants affected / at risk   27/371 (7.28%)   29/371 (7.82%) 
Muscle spasms * 1     
# participants affected / at risk   10/371 (2.70%)   27/371 (7.28%) 
Bone pain * 1     
# participants affected / at risk   19/371 (5.12%)   19/371 (5.12%) 
Musculoskeletal pain * 1     
# participants affected / at risk   20/371 (5.39%)   18/371 (4.85%) 
Nervous system disorders     
Dysgeusia * 1     
# participants affected / at risk   15/371 (4.04%)   41/371 (11.05%) 
Dizziness * 1     
# participants affected / at risk   21/371 (5.66%)   30/371 (8.09%) 
Neuropathy peripheral * 1     
# participants affected / at risk   4/371 (1.08%)   30/371 (8.09%) 
Headache * 1     
# participants affected / at risk   19/371 (5.12%)   28/371 (7.55%) 
Peripheral sensory neuropathy * 1     
# participants affected / at risk   5/371 (1.35%)   20/371 (5.39%) 
Renal and urinary disorders     
Haematuria * 1     
# participants affected / at risk   13/371 (3.50%)   58/371 (15.63%) 
Dysuria * 1     
# participants affected / at risk   5/371 (1.35%)   25/371 (6.74%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1     
# participants affected / at risk   16/371 (4.31%)   43/371 (11.59%) 
Cough * 1     
# participants affected / at risk   22/371 (5.93%)   40/371 (10.78%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1     
# participants affected / at risk   18/371 (4.85%)   37/371 (9.97%) 
Vascular disorders     
Hypotension * 1     
# participants affected / at risk   9/371 (2.43%)   19/371 (5.12%) 
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA 12.0



  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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