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. Identifier: NCT00417079
Recruitment Status : Completed
First Posted : December 29, 2006
Results First Posted : December 23, 2010
Last Update Posted : March 10, 2011
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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.

Condition or disease Intervention/treatment Phase
Neoplasms Prostatic Neoplasms Drug: cabazitaxel (XRP6258) (RPR116258) Drug: mitoxantrone Drug: prednisone Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 755 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

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U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Mitoxantrone + Prednisone
Mitoxantrone + Prednisone
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
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: Jevtana
Drug: prednisone
10 mg daily administered by oral route

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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)

  4. 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.

  5. 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.

  6. 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)

  7. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00417079

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United States, New Jersey
sanofi-aventis US
Bridgewater, New Jersey, United States, 08807
sanofi-aventis Argentina
Buenos Aires, Argentina
sanofi-aventis Belgium
Diegem, Belgium
sanofi-aventis Brazil
Sao Paulo, Brazil
Canada, Quebec
sanofi-aventis Canada
Laval, Quebec, Canada
sanofi-aventis Chile
Santiago, Chile
Czech Republic
sanofi-aventis Czech Republic
Praha, Czech Republic
sanofi-aventis Denmark
Horsholm, Denmark
sanofi-aventis Finland
Helsinki, Finland
sanofi-aventis France
Paris, France
sanofi-aventis Germany
Berlin, Germany
Sanofi-Aventis Hungaria
Budapest, Hungary
sanofi-aventis India
Mumbai, India
sanofi-aventis Italy
Milano, Italy
Korea, Republic of
sanofi-aventis South Korea
Seoul, Korea, Republic of
sanofi-aventis Mexico
Mexico, Mexico
sanofi-aventis Netherlands
Gouda, Netherlands
Russian Federation
sanofi-aventis Russia
Moscow, Russian Federation
sanofi-aventis Singapore
Singapore, Singapore
sanofi-aventis Slovakia
Bratislava, Slovakia
South Africa
sanofi-aventis South Africa
Midrand, South Africa
sanofi-aventis Spain
Barcelona, Spain
sanofi-aventis Sweden
Bromma, Sweden
sanofi-aventis Taiwan
Taipei, Taiwan
sanofi-aventis Turkey
Istanbul, Turkey
United Kingdom
sanofi-aventis UK
Guildford, Surrey, United Kingdom
Sponsors and Collaborators
Study Director: ICD Sanofi

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: International Clinical Development Study Director, sanofi-aventis Identifier: NCT00417079     History of Changes
Other Study ID Numbers: EFC6193
First Posted: December 29, 2006    Key Record Dates
Results First Posted: December 23, 2010
Last Update Posted: March 10, 2011
Last Verified: March 2011

Keywords provided by Sanofi:

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Sensory System Agents
Peripheral Nervous System Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action