Clinical trial NCT00417079: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neoplasms
Prostatic Neoplasms
Keywords: Cancer
Prostate
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-12-29
Enrollment: 755
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall Survival
timeFrame: From the date of randomization up to 104 weeks (study cut-off)
Secondary outcomes:
measure: Time to Progression Free Survival (PFS)
timeFrame: From the date of randomization up to 104 weeks (study cut-off)
measure: Overall Tumor Response
timeFrame: From the date of randomization up to 104 weeks (study cut-off)
measure: Time to Tumor Progression
timeFrame: From the date of randomization up to 104 weeks (study cut-off)
measure: Time to Prostatic Specific Antigen (PSA) Progression
timeFrame: at screening, day 1 of every treatment cycle, up to 104 weeks (study cut-off)
measure: PSA (Prostate-Specific Antigen) Response
timeFrame: from baseline up to 104 weeks (study cut-off)
measure: Time to Pain Progression
timeFrame: from baseline up to 104 weeks (study cut-off)
measure: Pain Response
timeFrame: from baseline up to 104 weeks (study cut-off)
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: sanofi-aventis US
state: New Jersey
city: Buenos Aires
country: Argentina
facility: sanofi-aventis Argentina
city: Diegem
country: Belgium
facility: sanofi-aventis Belgium
city: Sao Paulo
country: Brazil
facility: sanofi-aventis Brazil
city: Laval
country: Canada
facility: sanofi-aventis Canada
state: Quebec
city: Santiago
country: Chile
facility: sanofi-aventis Chile
city: Praha
country: Czech Republic
facility: sanofi-aventis Czech Republic
city: Horsholm
country: Denmark
facility: sanofi-aventis Denmark
city: Helsinki
country: Finland
facility: sanofi-aventis Finland
city: Paris
country: France
facility: sanofi-aventis France
city: Berlin
country: Germany
facility: sanofi-aventis Germany
city: Budapest
country: Hungary
facility: Sanofi-Aventis Hungaria
city: Mumbai
country: India
facility: sanofi-aventis India
city: Milano
country: Italy
facility: sanofi-aventis Italy
city: Seoul
country: Korea, Republic of
facility: sanofi-aventis South Korea
city: Mexico
country: Mexico
facility: sanofi-aventis Mexico
city: Gouda
country: Netherlands
facility: sanofi-aventis Netherlands
city: Moscow
country: Russian Federation
facility: sanofi-aventis Russia
city: Singapore
country: Singapore
facility: sanofi-aventis Singapore
city: Bratislava
country: Slovakia
facility: sanofi-aventis Slovakia
city: Midrand
country: South Africa
facility: sanofi-aventis South Africa
city: Barcelona
country: Spain
facility: sanofi-aventis Spain
city: Bromma
country: Sweden
facility: sanofi-aventis Sweden
city: Taipei
country: Taiwan
facility: sanofi-aventis Taiwan
city: Istanbul
country: Turkey
facility: sanofi-aventis Turkey
city: Guildford
country: United Kingdom
facility: sanofi-aventis UK
state: Surrey
Study officials:
affiliation: Sanofi
name: ICD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.