Overview

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

Status:
Completed
Trial end date:
2009-03-25
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bayer
Treatments:
Carboplatin
Sagopilone
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