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

CompletadoFase 3ClinicalTrials.gov

ID: NCT00417079Tipo: INTERVENTIONALInicio: 1 de ene de 2007Fin estimado: 1 de sept de 2009

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: MALE

Criterios de inclusión

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

Criterios de exclusión

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.

Intervenciones

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

Ubicaciones

sanofi-aventis Argentina

Buenos Aires, Argentina

Patrocinadores

PrincipalSanofi

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