Status:

COMPLETED

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

Lead Sponsor:

Bayer

Conditions:

Ovarian Neoplasms

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief 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 goo...

Detailed 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.

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

August 24 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 25 2009

Estimated Enrollment :

45 Patients enrolled

Trial Details

Trial ID

NCT00325351

Start Date

August 24 2006

End Date

March 25 2009

Last Update

April 8 2021

Active Locations (16)

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Page 1 of 4 (16 locations)

1

Tucson, Arizona, United States, 85724

2

Little Rock, Arkansas, United States, 72205

3

Bakersfield, California, United States, 93309

4

La Jolla, California, United States, 92093