Efficacy and Safety of Patupilone in Men (≥18 Years) With Metastatic Hormone Refractory Prostate Cancer

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00411528

Collaborator

(none)

185

Enrollment

Locations

Arms

Duration (Months)

5.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Hormone Refractory Prostate Cancer	Drug: Patupilone Drug: prednisone Drug: docetaxel	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

185 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1: 8 mg/m2 study drug + prednisone Patupilone 8 mg/m2 + prednisone 5 mg bid daily	Drug: Patupilone Other Names: EPO906 Drug: prednisone
Experimental: 2: study drug + prednisone days 1 -8 Patupilone 10 mg/m2 + prednisone days 1 -8 at 25 mg bid, day 9 at 20 mg bid, day 10 at 15 mg bid, day 11 at 10 mg bid, day 12 - 21 at 5 mg bid	Drug: Patupilone Other Names: EPO906 Drug: prednisone
Experimental: 3: Study drug + prednisone days 1 - 4 Patupilone 10 mg/m2 + prednisone days 1 - 4 at 5 mg bid, days 5 -12 at 25 mg bid, day 13 at 20 mg bid, day 14 at 15 mg bid, day 15 at 10 mg bid, day 16 - 21 at 5 mg bid	Drug: Patupilone Other Names: EPO906 Drug: prednisone
Active Comparator: 4: Docetaxel 75 mg/m2 + prednisone 5 mg bid daily Docetaxel 75 mg/m2 once every 3 weeks + prednisone 5 mg bid daily	Drug: prednisone Drug: docetaxel

Outcome Measures

Primary Outcome Measures

Antitumor response based on PSA decrease [Every 3 weeks]

Secondary Outcome Measures

Measurable soft tissue response for both regimens [Every 6 weeks or every 12 weeks if patient has bone disease for bone scan]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California San Diego Dept of Moores Cancer Center	La Jolla	California	United States	92093-0658
2	University of Colorado Dept. of Univ. of Colorado	Aurora	Colorado	United States	80045
3	Norwalk Hospital	Norwalk	Connecticut	United States	06856
4	Georgetown University/Lombardi Cancer Center Dept.of Lombardi Cancer Center	Washington	District of Columbia	United States	20007-2197
5	MD Anderson Cancer Center - Orlando CEPO906A2229	Orlando	Florida	United States	32806
6	H. Lee Moffitt Cancer Center/University of South Florida Department of Genitourology	Tampa	Florida	United States	33612
7	Palm Beach Cancer Institute	West Palm Beach	Florida	United States	33401
8	NorthWest Georgia Oncology Centers Marietta Center	Marietta	Georgia	United States	30060
9	University Chicago Hospital StudyCoordinator:CEPO906A2229	Chicago	Illinois	United States	60637
10	Queens Cancer Center of Queens Hospital	Jamaica	New York	United States	11432
11	Oregon Health & Science University StudyCoordinator:CEPO906A2229	Portland	Oregon	United States	97239
12	Novartis Investigative Site	Kogarah	New South Wales	Australia	2217
13	Novartis Investigative Site	South Brisbane	Queensland	Australia	4101
14	Novartis Investigative Site	Parkville	Victoria	Australia	3050
15	Novartis Investigative Site	Gent		Belgium	9000
16	Novartis Investigative Site	Bordeaux Cedex		France	33075
17	Novartis Investigative Site	Colmar Cedex		France	68024
18	Novartis Investigative Site	Lille Cedex		France	59020
19	Novartis Investigative Site	Rouen Cedex		France	76031
20	Novartis Investigative Site	Strasbourg		France	67091
21	Novartis Investigative Site	Toulouse Cedex 3		France	31052
22	Novartis Investigative Site	Mannheim		Germany	68135
23	Novartis Investigative Site	Weiden		Germany	92637
24	Novartis Investigative Site	Milano	MI	Italy	20133
25	Novartis Investigative Site	Milano	MI	Italy	20141
26	Novartis Investigative Site	Perugia	PG	Italy	06129
27	Novartis Investigative Site	Singapore		Singapore	169610
28	Novartis Investigative Site	Malaga	Andalucía	Spain	29010
29	Novartis Investigative Site	Barcelona	Catalunya	Spain	08036
30	Novartis Investigative Site	Valencia	Comunidad Valenciana	Spain	46009
31	Novartis Investigative Site	Madrid		Spain	28034
32	Novartis Investigative Site	Madrid		Spain	28041