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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00325351

Collaborator

(none)

Enrollment

Locations

Arm

Actual Duration (Months)

2.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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 good response with cisplatin or carboplatin, is safe and helps to decrease or stop tumor growth.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Neoplasms	Drug: Sagopilone (ZK 219477) + carboplatin	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase 1/2 Study of ZK-Epothilone (ZK-Epo; ZK-219477) in Combination With Carboplatin in Patients With Platinum-sensitive Recurrent Ovarian Cancer

Actual Study Start Date :

Aug 24, 2006

Actual Primary Completion Date :

Jul 8, 2008

Actual Study Completion Date :

Mar 25, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Sagopilone (ZK 219477) + carboplatin Chemotherapy for recurrent ovarian cancer

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: Sagopilone (ZK 219477) + carboplatin

Chemotherapy for recurrent ovarian cancer

Outcome Measures

Primary Outcome Measures

Response to treatment with ZK-Epo after 6 cycles [After 6 cycles]

Secondary Outcome Measures

Safety and tolerability of ZK-Epo given with carboplatin [Sept. 2008]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country	Postal Code
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
5	San Diego	California	United States	92121
6	Savannah	Georgia	United States	31404
7	South Bend	Indiana	United States	46617
8	Baltimore	Maryland	United States	21204
9	Albuquerque	New Mexico	United States	87131
10	Winston-Salem	North Carolina	United States	27157
11	Cleveland	Ohio	United States	44109
12	Oklahoma City	Oklahoma	United States	73104
13	Knoxville	Tennessee	United States	37920
14	Roanoke	Virginia	United States	24014
15	Calgary	Alberta	Canada	T2N 4N2
16	Toronto	Ontario	Canada	M4N 3M5