XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer
Condition: Neoplasms; Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms; Neoplasms
Intervention: cabazitaxel (XRP6258) (RPR116258); mitoxantrone; prednisone
Intervention description: 25 mg/m^2 administered by intravenous (IV) route over 1 hour on day 1 of each 21-day cycle; 12 mg/m^2 administered by intravenous (IV) route over 15-30 minutes on day 1 of each 21-day cycle; 10 mg daily administered by oral route
Intervention MeSH terms: Prednisone; Mitoxantrone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 755.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer; Prostate

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.
    

Eligibility 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.