Clinical trial NCT00350051: ZK-Epo Given With Prednisone in Patients With Metastatic Androgen-independent Prostate Cancer
Official title: Phase 2 Study of ZK-Epothilone (ZK-Epo; ZK219477) Plus Prednisone as First-line Chemotherapy in Patients With Metastatic Androgen-independent Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate cancer
Metastatic androgen-independent prostate cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-07-10
Enrollment: 53
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) given with prednisone in patients with androgen-independent prostate cancer, who have not had previous chemotherapy, is safe and helps to decrease PSA (Prostate-specific antigen) levels.

Detailed description: This study has previously been posted by Berlex, Inc. and Schering AG, Germany.Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer HealthCare Pharmaceuticals, Inc.and Bayer Schering Pharma AG, Germany are the sponsors of the trial.

Eligibility criteria: Inclusion Criteria:

* Must have evidence of confirmed metastatic prostate cancer
* Serum testosterone must be less than 50 ng/mL
* Disease must be progressing despite anti-androgen therapy
* PSA level must be elevated
* Additional criteria determined at screening visit

Exclusion Criteria:

* Any previous cytotoxic chemotherapy for prostate cancer
* Use of any investigational drug in the last 4 weeks
* Symptomatic brain tumors requiring radiation to the brain
* Active infection
* Additional criteria determined at screening visit

Primary outcomes:
measure: PSA Response to treatment with ZK-Epo plus prednisone after 6 cycles
timeFrame: at least 28 days post day 21 of last cycle of treatment
Secondary outcomes:
measure: Safety & Tolerability of ZK-Epo plus prednisone
timeFrame: until progression, unknown duration
Other outcomes:
Locations:
city: Fountain Valley
country: United States
state: California
city: Sarasota
country: United States
state: Florida
city: Baltimore
country: United States
state: Maryland
city: Ann Arbor
country: United States
state: Michigan
city: Billings
country: United States
state: Montana
city: Omaha
country: United States
state: Nebraska
city: Bronx
country: United States
state: New York
city: Canton
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Altoona
country: United States
state: Pennsylvania
city: Fort Worth
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
city: Buenos Aires
country: Argentina
state: Ciudad Auton. De Buenos Aires
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Córdoba
country: Argentina
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Beer TM, Smith DC, Hussain A, Alonso M, Wang J, Giurescu M, Roth K, Wang Y. Phase II study of first-line sagopilone plus prednisone in patients with castration-resistant prostate cancer: a phase II study of the Department of Defense Prostate Cancer Clinical Trials Consortium. Br J Cancer. 2012 Aug 21;107(5):808-13. doi: 10.1038/bjc.2012.339. Epub 2012 Jul 31.