Clinical trial NCT00411528: Efficacy and Safety of Patupilone in Men (≥18 Years) With Metastatic Hormone Refractory Prostate Cancer
Official title: A Randomized Multicenter Phase II Trial of Patupilone (EPO906) Plus Prednisone Versus Docetaxel Plus Prednisone in Patients With Metastatic Hormone Refractory Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Hormone Refractory Prostate Cancer
Keywords: Prostate Cancer
Hormone Refractory
patupilone
docetaxel
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-12-14
Enrollment: 185
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: The objective of this study is to assess the response of patupilone plus prednisone compared to docetaxel plus prednisone on prostate specific antigen (PSA) in patients with metastatic hormone refractory prostate cancer. Additionally, this study will assess the response on measureable disease and the effects on patient-reported outcomes.


Eligibility criteria: Inclusion criteria:

* Must be ≥ 18 years of age
* Confirmed and documented diagnosis of prostate cancer
* Confirmed and documented evidence of progression of disease (hormone refractory)
* Low testosterone levels
* Chemotherapy-naïve

Exclusion criteria:

* Recent radiation therapy (within 4 weeks)
* Known brain metastasis
* Peripheral neuropathy
* Active diarrhea
* Significant illnesses such as heart disease, diabetes, or chronic or uncontrolled infections
* Allergic reactions to patupilone or docetaxel or prednisone or similar compounds

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Antitumor response based on PSA decrease
timeFrame: Every 3 weeks
Secondary outcomes:
measure: Measurable soft tissue response for both regimens
timeFrame: Every 6 weeks or every 12 weeks if patient has bone disease for bone scan
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego Dept of Moores Cancer Center
state: California
city: Aurora
country: United States
facility: University of Colorado Dept. of Univ. of Colorado
state: Colorado
city: Norwalk
country: United States
facility: Norwalk Hospital
state: Connecticut
city: Washington
country: United States
facility: Georgetown University/Lombardi Cancer Center Dept.of Lombardi Cancer Center
state: District of Columbia
city: Orlando
country: United States
facility: MD Anderson Cancer Center - Orlando CEPO906A2229
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center/University of South Florida Department of Genitourology
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Cancer Institute
state: Florida
city: Marietta
country: United States
facility: NorthWest Georgia Oncology Centers Marietta Center
state: Georgia
city: Chicago
country: United States
facility: University Chicago Hospital StudyCoordinator:CEPO906A2229
state: Illinois
city: Jamaica
country: United States
facility: Queens Cancer Center of Queens Hospital
state: New York
city: Portland
country: United States
facility: Oregon Health & Science University StudyCoordinator:CEPO906A2229
state: Oregon
city: Kogarah
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: South Brisbane
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Parkville
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Gent
country: Belgium
facility: Novartis Investigative Site
city: Bordeaux Cedex
country: France
facility: Novartis Investigative Site
city: Colmar Cedex
country: France
facility: Novartis Investigative Site
city: Lille Cedex
country: France
facility: Novartis Investigative Site
city: Rouen Cedex
country: France
facility: Novartis Investigative Site
city: Strasbourg
country: France
facility: Novartis Investigative Site
city: Toulouse Cedex 3
country: France
facility: Novartis Investigative Site
city: Mannheim
country: Germany
facility: Novartis Investigative Site
city: Weiden
country: Germany
facility: Novartis Investigative Site
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Perugia
country: Italy
facility: Novartis Investigative Site
state: PG
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucía
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: de Liano AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.