Ovarian Cancer Clinical Trial

ZK-Epo Given With Carboplatin in Patients With Recurrent Ovarian Cancer

Summary

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.

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Full Description

This study has previously been registered by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc. is sponsoring this trial.

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Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

45

Study ID:

NCT00325351

Recruitment Status:

Completed

Sponsor:

Bayer

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There are 16 Locations for this study

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Tucson Arizona, 85724, United States

Little Rock Arkansas, 72205, United States

Bakersfield California, 93309, United States

La Jolla California, 92093, United States

San Diego California, 92121, United States

Savannah Georgia, 31404, United States

South Bend Indiana, 46617, United States

Baltimore Maryland, 21204, United States

Albuquerque New Mexico, 87131, United States

Winston-Salem North Carolina, 27157, United States

Cleveland Ohio, 44109, United States

Oklahoma City Oklahoma, 73104, United States

Knoxville Tennessee, 37920, United States

Roanoke Virginia, 24014, United States

Calgary Alberta, T2N 4, Canada

Toronto Ontario, M4N 3, Canada

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

45

Study ID:

NCT00325351

Recruitment Status:

Completed

Sponsor:


Bayer

How clear is this clinincal trial information?

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