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

NCT00417079 | Completed Phase 3 Results

• 1 other identifier: EFC6193
• Study Type: interventional
• Target: 755
• Locations: 26 countries
• Sites: 26

Brief 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.

Conditions

Neoplasms; Prostatic Neoplasms

Keywords

Cancer; Prostate

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  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.

  From the date of randomization up to 104 weeks (study cut-off)

Secondary Outcomes (7)

• Time to Progression Free Survival (PFS)

  From the date of randomization up to 104 weeks (study cut-off)

• Overall Tumor Response

  From the date of randomization up to 104 weeks (study cut-off)

• Time to Tumor Progression

  From the date of randomization up to 104 weeks (study cut-off)

• Time to Prostatic Specific Antigen (PSA) Progression

  at screening, day 1 of every treatment cycle, up to 104 weeks (study cut-off)

• PSA (Prostate-Specific Antigen) Response

  from baseline up to 104 weeks (study cut-off)

Study Arms (2)

Mitoxantrone + Prednisone

ACTIVE COMPARATOR

Mitoxantrone + Prednisone

Drug: mitoxantrone; Drug: prednisone

Cabazitaxel + Prednisone

EXPERIMENTAL

Cabazitaxel + Prednisone

Drug: cabazitaxel (XRP6258) (RPR116258); Drug: prednisone

Interventions

cabazitaxel (XRP6258) (RPR116258) DRUG

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

Also known as: Jevtana

Cabazitaxel + Prednisone

mitoxantrone DRUG

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

Mitoxantrone + Prednisone

prednisone DRUG

10 mg daily administered by oral route

Cabazitaxel + Prednisone; Mitoxantrone + Prednisone

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (26)

sanofi-aventis US

Bridgewater, New Jersey, 08807, United States

Location

sanofi-aventis Argentina

Buenos Aires, Argentina

Location

sanofi-aventis Belgium

Diegem, Belgium

Location

sanofi-aventis Brazil

São Paulo, Brazil

Location

sanofi-aventis Canada

Laval, Quebec, Canada

Location

sanofi-aventis Chile

Santiago, Chile

Location

sanofi-aventis Czech Republic

Prague, Czechia

Location

sanofi-aventis Denmark

Hørsholm, Denmark

Location

sanofi-aventis Finland

Helsinki, Finland

Location

sanofi-aventis France

Paris, France

Location

sanofi-aventis Germany

Berlin, Germany

Location

Sanofi-Aventis Hungaria

Budapest, Hungary

Location

sanofi-aventis India

Mumbai, India

Location

sanofi-aventis Italy

Milan, Italy

Location

sanofi-aventis Mexico

México, Mexico

Location

sanofi-aventis Netherlands

Gouda, Netherlands

Location

sanofi-aventis Russia

Moscow, Russia

Location

sanofi-aventis Singapore

Singapore, Singapore

Location

sanofi-aventis Slovakia

Bratislava, Slovakia

Location

sanofi-aventis South Africa

Midrand, South Africa

Location

sanofi-aventis South Korea

Seoul, South Korea

Location

sanofi-aventis Spain

Barcelona, Spain

Location

sanofi-aventis Sweden

Bromma, Sweden

Location

sanofi-aventis Taiwan

Taipei, Taiwan

Location

sanofi-aventis Turkey

Istanbul, Turkey (Türkiye)

Location

sanofi-aventis UK

Guildford, Surrey, United Kingdom

Location

Related Publications (4)

• Lorente D, Mateo J, Templeton AJ, Zafeiriou Z, Bianchini D, Ferraldeschi R, Bahl A, Shen L, Su Z, Sartor O, de Bono JS. Baseline neutrophil-lymphocyte ratio (NLR) is associated with survival and response to treatment with second-line chemotherapy for advanced prostate cancer independent of baseline steroid use. Ann Oncol. 2015 Apr;26(4):750-755. doi: 10.1093/annonc/mdu587. Epub 2014 Dec 23.

  PMID: 25538172 DERIVED

• Bahl A, Oudard S, Tombal B, Ozguroglu M, Hansen S, Kocak I, Gravis G, Devin J, Shen L, de Bono JS, Sartor AO; TROPIC Investigators. Impact of cabazitaxel on 2-year survival and palliation of tumour-related pain in men with metastatic castration-resistant prostate cancer treated in the TROPIC trial. Ann Oncol. 2013 Sep;24(9):2402-8. doi: 10.1093/annonc/mdt194. Epub 2013 May 30.

  PMID: 23723295 DERIVED

• Pouessel D, Oudard S, Gravis G, Priou F, Shen L, Culine S. [Cabazitaxel for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: the TROPIC study in France]. Bull Cancer. 2012 Jul-Aug;99(7-8):731-41. doi: 10.1684/bdc.2012.1608. French.

  PMID: 22743148 DERIVED

• de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, Gravis G, Bodrogi I, Mackenzie MJ, Shen L, Roessner M, Gupta S, Sartor AO; TROPIC Investigators. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010 Oct 2;376(9747):1147-54. doi: 10.1016/S0140-6736(10)61389-X.

  PMID: 20888992 DERIVED

MeSH Terms

Conditions

Neoplasms; Prostatic Neoplasms

Interventions

cabazitaxel; XRP6258; Mitoxantrone; Prednisone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quinones; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Results Point of Contact

• Title: International Clinical Development Study Director
• Organization: sanofi-aventis

GV-Contact-us@sanofi-aventis.com

Study Officials

• ICD

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 28, 2006
• First Posted: December 29, 2006
• Study Start: January 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: March 10, 2011
• Results First Posted: December 23, 2010

Record last verified: 2011-03

Locations

CZ (1); SG (1); IT (1); ZA (1); SE (1); FI (1); AR (1); FR (1); KR (1); DE (1); CA (1); GB (1); RU (1); BE (1); HU (1); DK (1); ME (1); NL (1); SL (1); TU (1); BR (1); IN (1); CL (1); ES (1); TW (1); US (1)