XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer
NCT ID: NCT00417079
Last Updated: 2011-03-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
755 participants
INTERVENTIONAL
2007-01-31
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mitoxantrone + Prednisone
Mitoxantrone + Prednisone
mitoxantrone
12 mg/m\^2 administered by intravenous (IV) route over 15-30 minutes on day 1 of each 21-day cycle
prednisone
10 mg daily administered by oral route
Cabazitaxel + Prednisone
Cabazitaxel + Prednisone
cabazitaxel (XRP6258) (RPR116258)
25 mg/m\^2 administered by intravenous (IV) route over 1 hour on day 1 of each 21-day cycle
prednisone
10 mg daily administered by oral route
Interventions
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cabazitaxel (XRP6258) (RPR116258)
25 mg/m\^2 administered by intravenous (IV) route over 1 hour on day 1 of each 21-day cycle
mitoxantrone
12 mg/m\^2 administered by intravenous (IV) route over 15-30 minutes on day 1 of each 21-day cycle
prednisone
10 mg daily administered by oral route
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
MALE
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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ICD
Role: STUDY_DIRECTOR
Sanofi
Locations
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sanofi-aventis US
Bridgewater, New Jersey, United States
sanofi-aventis Argentina
Buenos Aires, , Argentina
sanofi-aventis Belgium
Diegem, , Belgium
sanofi-aventis Brazil
São Paulo, , Brazil
sanofi-aventis Canada
Laval, Quebec, Canada
sanofi-aventis Chile
Santiago, , Chile
sanofi-aventis Czech Republic
Prague, , Czechia
sanofi-aventis Denmark
Hørsholm, , Denmark
sanofi-aventis Finland
Helsinki, , Finland
sanofi-aventis France
Paris, , France
sanofi-aventis Germany
Berlin, , Germany
Sanofi-Aventis Hungaria
Budapest, , Hungary
sanofi-aventis India
Mumbai, , India
sanofi-aventis Italy
Milan, , Italy
sanofi-aventis Mexico
México, , Mexico
sanofi-aventis Netherlands
Gouda, , Netherlands
sanofi-aventis Russia
Moscow, , Russia
sanofi-aventis Singapore
Singapore, , Singapore
sanofi-aventis Slovakia
Bratislava, , Slovakia
sanofi-aventis South Africa
Midrand, , South Africa
sanofi-aventis South Korea
Seoul, , South Korea
sanofi-aventis Spain
Barcelona, , Spain
sanofi-aventis Sweden
Bromma, , Sweden
sanofi-aventis Taiwan
Taipei, , Taiwan
sanofi-aventis Turkey
Istanbul, , Turkey (Türkiye)
sanofi-aventis UK
Guildford, Surrey, United Kingdom
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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EFC6193
Identifier Type: -
Identifier Source: org_study_id
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