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Completed

NCT Number: NCT00417079

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

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.

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Key information

Conditions

Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

sanofi-aventis Argentina, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically confirmed adenocarcinoma of the prostate that is refractory to hormone therapy and previously treated with a Taxotere®-containing regimen.
  • 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.
  • Surgical or hormone-induced castration
  • Life expectancy > 2 months
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2

Exclusion criteria

  • Previous treatment with mitoxantrone
  • Previous treatment with <225 mg/m^2 cumulative dose of Taxotere (or docetaxel)
  • Prior radiotherapy to ≥ 40% of bone marrow
  • Surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment in the study
  • 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
  • Known brain or leptomeningeal involvement
  • Other concurrent serious illness or medical conditions
  • Inadequate organ function evidenced by unacceptable laboratory results

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

Treatment and study plan

cabazitaxel (XRP6258) (RPR116258)

Drug

25 mg/m^2 administered by intravenous (IV) route over 1 hour on day 1 of each 21-day cycle

Other names: Jevtana

Mitoxantrone

Drug

12 mg/m^2 administered by intravenous (IV) route over 15-30 minutes on day 1 of each 21-day cycle

Prednisone

Drug

10 mg daily administered by oral route

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: TROPIC

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 29, 2006
Registry last updated
Mar 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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