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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
  Purpose

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 Intervention Phase
Neoplasms
Prostatic Neoplasms
Drug: cabazitaxel (XRP6258) (RPR116258)
Drug: mitoxantrone
Drug: prednisone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: From the date of randomization up to 104 weeks (study cut-off) ] [ Designated as safety issue: No ]

    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:
  • Time to Progression Free Survival (PFS) [ Time Frame: From the date of randomization up to 104 weeks (study cut-off) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 755
Study Start Date: January 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417079

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

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: International Clinical Development Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00417079     History of Changes
Other Study ID Numbers: EFC6193
Study First Received: December 28, 2006
Results First Received: September 20, 2010
Last Updated: March 4, 2011
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada

Keywords provided by Sanofi:
Cancer
Prostate

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

ClinicalTrials.gov processed this record on November 19, 2014