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

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”

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.

Intervention(s) in this Clinical Trial

• Drug: cabazitaxel (XRP6258) (RPR116258)
  • 25 mg/m^2 administered by intravenous (IV) route over 1 hour on day 1 of each 21-day cycle
• 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Mitoxantrone + Prednisone
  • Mitoxantrone + Prednisone
• Experimental: Cabazitaxel + Prednisone
  • Cabazitaxel + Prednisone

Primary Measures

• Overall Survival
  • Time Frame: From the date of randomization up to 104 weeks (study cut-off)
    Safety Issue?: No

Secondary Measures

• Time to Progression Free Survival (PFS)
  • Time Frame: From the date of randomization up to 104 weeks (study cut-off)
    Safety Issue?: No
• Overall Tumor Response
  • Time Frame: From the date of randomization up to 104 weeks (study cut-off)
    Safety Issue?: No
• Time to Tumor Progression
  • Time Frame: From the date of randomization up to 104 weeks (study cut-off)
    Safety Issue?: No
• Time to Prostatic Specific Antigen (PSA) Progression
  • Time Frame: at screening, day 1 of every treatment cycle, up to 104 weeks (study cut-off)
    Safety Issue?: No
• PSA (Prostate-Specific Antigen) Response
  • Time Frame: from baseline up to 104 weeks (study cut-off)
    Safety Issue?: No
• Time to Pain Progression
  • Time Frame: from baseline up to 104 weeks (study cut-off)
    Safety Issue?: No
• Pain Response
  • Time Frame: from baseline up to 104 weeks (study cut-off)
    Safety Issue?: 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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Sanofi-Aventis Industry

Overall Clinical Trial Officials and Contacts

ICD Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00417079

Study ID Number: EFC6193

ClinicalTrials.gov Identifier: NCT00417079

Health Authority: United States: Food and Drug Administration