Phase 3
N=755
XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer
Neoplasms · Prostatic Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00417079 ↗Enrolled (actual)
755
Serious AEs
29.9%
Results posted
Dec 2010
Primary outcome: Primary: Overall Survival — 12.7; 15.1 Months — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- cabazitaxel (XRP6258) (RPR116258) (Drug); mitoxantrone (Drug); prednisone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Sanofi
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
12.7; 15.1 | <0.0001 sig |
| SECONDARY Time to Progression Free Survival (PFS) |
1.4; 2.8 | <0.0001 sig |
| SECONDARY Overall Tumor Response |
4.4; 14.4 | 0.0005 sig |
| SECONDARY Time to Tumor Progression |
5.4; 8.8 | <0.0001 sig |
| SECONDARY Time to Prostatic Specific Antigen (PSA) Progression |
3.1; 6.4 | 0.0010 sig |
| SECONDARY PSA (Prostate-Specific Antigen) Response |
17.8; 39.2 | 0.0002 sig |
| SECONDARY Time to Pain Progression |
NA; 11.1 | 0.5192 |
| SECONDARY Pain Response |
7.7; 9.2 | 0.6286 |
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
- 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.
Data sourced from ClinicalTrials.gov (NCT00417079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.