Trial Condition(s):

Ovarian Neoplasms

ZK-Epo given with carboplatin in patients with recurrent ovarian cancer

Bayer Identifier:

91476

ClinicalTrials.gov Identifier:

NCT00325351

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) given with carboplatin in patients with recurrent ovarian cancer, who previously have had a good response with cisplatin or carboplatin, is safe and helps to decrease or stop tumor growth.

Inclusion Criteria
- Must have evidence of ovarian cancer measurable by computed tomography (CT) scan or by CA125 blood levels- No radiation therapy in last 4 weeks- No chemotherapy in last 24 weeks - No immunotherapy in last 4 weeks- Good response after previous treatment with carboplatin or cisplatin and then the ovarian cancer got worse again after at least 6 months- Additional criteria determined at screening visit
Exclusion Criteria
- Having had more than one treatment regimen with carboplatin or cisplatin- Prior treatment with other epothilones (e.g. ixabepilone)- Use of any investigational drug in the last  4 weeks- Previous radiation to the whole pelvis- Symptomatic brain tumors requiring radiation to the brain - Active infection- Pregnant or breast feeding- Additional criteria determined at screening visit

Trial Summary

Enrollment Goal
45
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
Sagopilone (BAY86-5302)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Albuquerque, United States, 87131

Status
Completed
 
Locations

Investigative Site

Little Rock, United States, 72205

Status
Completed
 
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Investigative Site

Toronto, Canada, M4N 3M5

Status
Completed
 
Locations

Investigative Site

Savannah, United States, 31404

Status
Completed
 
Locations

Investigative Site

Roanoke, United States, 24014

Status
Completed
 
Locations

Investigative Site

Bakersfield, United States, 93309

Status
Completed
 
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Investigative Site

Cleveland, United States, 44109

Status
Completed
 
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Investigative Site

Calgary, Canada, T2N 4N2

Status
Completed
 
Locations

Investigative Site

Winston-Salem, United States, 27157

Status
Completed
 
Locations

Investigative Site

Baltimore, United States, 21204

Status
Completed
 
Locations

Investigative Site

Oklahoma City, United States, 73104

Status
Completed
 
Locations

Investigative Site

Knoxville, United States, 37920

Status
Completed
 
Locations

Investigative Site

South Bend, United States, 46617

Status
Completed
 
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Investigative Site

San Diego, United States, 92121

Status
Completed
 
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Investigative Site

Tucson, United States, 85724

Status
Completed
 
Locations

Investigative Site

La Jolla, United States, 92093

Status
Completed
 

Trial Design