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

NCT00325351CompletedPHASE2INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Bayer

Enrollment

45

Start Date

2006-08-24

Completion Date

2008-07-08

Study Type

INTERVENTIONAL

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

Interventions

Sagopilone (ZK 219477) + carboplatin

Conditions

Ovarian Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

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

Locations

Tucson, United States

Little Rock, United States

Bakersfield, United States

La Jolla, United States

San Diego, United States

Savannah, United States

South Bend, United States

Baltimore, United States

Albuquerque, United States

Winston-Salem, United States

Cleveland, United States

Oklahoma City, United States

Knoxville, United States

Roanoke, United States

Calgary, Canada

Toronto, Canada