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A Randomized Multicenter Phase II Trial of Patupilone (EPO906) Plus Prednisone Versus Docetaxel Plus Prednisone in Patients With Metastatic Hormone Refractory Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Metastatic Hormone Refractory Prostate Cancer

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Trial Information

A Randomized Multicenter Phase II Trial of Patupilone (EPO906) Plus Prednisone Versus Docetaxel Plus Prednisone in Patients With Metastatic Hormone Refractory Prostate Cancer

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antitumor response based on PSA decrease

Outcome Time Frame:

Every 3 weeks

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CEPO906A2229

NCT ID:

NCT00411528

Start Date:

September 2006

Completion Date:

September 2012

Related Keywords:

  • Metastatic Hormone Refractory Prostate Cancer
  • Prostate Cancer
  • Hormone Refractory
  • patupilone
  • docetaxel
  • Prostatic Neoplasms

Name

Location

Queens Cancer Center of Queens HospitalJamaica, New York  11432
Palm Beach Cancer InstituteWest Palm Beach, Florida  33401
Norwalk HospitalNorwalk, Connecticut  06856
NorthWest Georgia Oncology Centers Marietta CenterMarietta, Georgia  30060
University of California San Diego Dept of Moores Cancer CenterLa Jolla, California  92093-0658
University of Colorado Dept. of Univ. of ColoradoAurora, Colorado  80045
Georgetown University/Lombardi Cancer Center Dept.of Lombardi Cancer CenterWashington, District of Columbia  20007-2197
MD Anderson Cancer Center - Orlando CEPO906A2229Orlando, Florida  32806
H. Lee Moffitt Cancer Center/University of South Florida Department of GenitourologyTampa, Florida  33612
University Chicago Hospital StudyCoordinator:CEPO906A2229Chicago, Illinois  60637
Oregon Health & Science University StudyCoordinator:CEPO906A2229Portland, Oregon  97239