Study Completed

Ovarian neoplasms

Bayer Identifier:

91476

ClinicalTrials.gov Identifier:

NCT00325351

EudraCT Number:

Not Available

EU CT Number:

Not Available

ZK-Epo given with carboplatin in patients with recurrent ovarian cancer

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

18 Years

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

Trial summary

Enrollment Goal

Trial Dates

August 2006 - March 2009

Phase

Phase 2

Could I Receive a placebo

Products

Sagopilone (BAY86-5302)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Albuquerque, 87131, United States
Completed		Little Rock, 72205, United States
Completed		Toronto, M4N 3M5, Canada
Completed		Savannah, 31404, United States
Completed		Roanoke, 24014, United States
Completed		Bakersfield, 93309, United States
Completed		Cleveland, 44109, United States
Completed		Calgary, T2N 4N2, Canada
Completed		Winston-Salem, 27157, United States
Completed		Baltimore, 21204, United States
Completed		Oklahoma City, 73104, United States
Completed		Knoxville, 37920, United States
Completed		South Bend, 46617, United States
Completed		San Diego, 92121, United States
Completed		Tucson, 85724, United States
Completed		La Jolla, 92093, United States

Primary Outcome

Response to treatment with ZK-Epo after 6 cycles
Time Frame:
After 6 cycles
Safety Issue:
no

Secondary Outcome

Safety and tolerability of ZK-Epo given with carboplatin
Time Frame:
Sept. 2008
Safety Issue:
yes

Trial design

Phase 1/2 study of ZK-Epothilone (ZK-Epo; ZK-219477) in combination with carboplatin in patients with platinum-sensitive recurrent ovarian cancer

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Non-randomized

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

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