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

Bayer45 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ovarian Neoplasms

Interventions

Sagopilone (ZK 219477) + carboplatinDRUG

Chemotherapy for recurrent ovarian cancer

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (16)

Unnamed facility

Tucson, Arizona, United States

Unnamed facility

Little Rock, Arkansas, United States

Unnamed facility

Bakersfield, California, United States

Outcomes

Primary Outcomes

Response to treatment with ZK-Epo after 6 cycles

Time frame: After 6 cycles

Secondary Outcomes

Safety and tolerability of ZK-Epo given with carboplatin

Time frame: Sept. 2008

Data from ClinicalTrials.gov

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