Clinical trial NCT00325351: ZK-Epo Given With Carboplatin in Patients With Recurrent Ovarian Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Neoplasms
Keywords: Ovarian cancer
Ovarian neoplasms, epithelium
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-05-12
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Response to treatment with ZK-Epo after 6 cycles
timeFrame: After 6 cycles
Secondary outcomes:
measure: Safety and tolerability of ZK-Epo given with carboplatin
timeFrame: Sept. 2008
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Bakersfield
country: United States
state: California
city: La Jolla
country: United States
state: California
city: San Diego
country: United States
state: California
city: Savannah
country: United States
state: Georgia
city: South Bend
country: United States
state: Indiana
city: Baltimore
country: United States
state: Maryland
city: Albuquerque
country: United States
state: New Mexico
city: Winston-Salem
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Knoxville
country: United States
state: Tennessee
city: Roanoke
country: United States
state: Virginia
city: Calgary
country: Canada
state: Alberta
city: Toronto
country: Canada
state: Ontario
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: McMeekin S, Patel R, Verschraegen C, Celano P, Burke J 2nd, Plaxe S, Ghatage P, Giurescu M, Stredder C, Wang Y, Schmelter T. Phase I/II study of sagopilone (ZK-EPO) plus carboplatin in women with recurrent platinum-sensitive ovarian cancer. Br J Cancer. 2012 Jan 3;106(1):70-6. doi: 10.1038/bjc.2011.499. Epub 2011 Nov 22.