ZK-Epo Given With Carboplatin in Patients With Recurrent Ovarian Cancer - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00325351

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.

Condition	Intervention	Phase
Ovarian Neoplasms	Drug: SH-Y03757A (ZK-Epothilone; ZK-219477) with carboplatin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Carboplatin Ixabepilone

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Response to treatment with ZK-Epo after 6 cycles [ Time Frame: After 6 cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability of ZK-Epo given with carboplatin [ Time Frame: Sept. 2008 ] [ Designated as safety issue: Yes ]

Enrollment:	45
Study Start Date:	August 2006
Study Completion Date:	March 2009
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: SH-Y03757A (ZK-Epothilone; ZK-219477) with carboplatin Chemotherapy for recurrent ovarian cancer

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325351

Locations

United States, Arizona

Tucson, Arizona, United States, 85724
United States, Arkansas

Little Rock, Arkansas, United States, 72205
United States, California

Bakersfield, California, United States, 93309

San Diego, California, United States, 92128

La Jolla, California, United States, 92093
United States, Georgia

Savannah, Georgia, United States, 31404
United States, Indiana

South Bend, Indiana, United States, 46617
United States, Maryland

Baltimore, Maryland, United States, 21204
United States, New Mexico

Albuquerque, New Mexico, United States, 87131
United States, North Carolina

Winston-Salem, North Carolina, United States, 27157
United States, Ohio

Cleveland, Ohio, United States, 44109-1998
United States, Oklahoma

Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee

Knoxville, Tennessee, United States, 37920
United States, Virginia

Roanoke, Virginia, United States, 24014
Canada, Alberta

Calgary, Alberta, Canada, T2N 4N2
Canada, Ontario

Toronto, Ontario, Canada, M4N 3M5

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

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No publications provided

Responsible Party:	Bayer Healthcare Pharmaceuticals Inc. ( Therapeutic Area Head )
Study ID Numbers:	91476, 307979
Study First Received:	May 11, 2006
Last Updated:	July 14, 2009
ClinicalTrials.gov Identifier:	NCT00325351 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Bayer:

Ovarian cancer
Ovarian neoplasms, epithelium

Study placed in the following topic categories:

Ovarian Neoplasms
Gonadal Disorders
Epothilones
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Antimitotic Agents
Ovarian Diseases

Carboplatin
Recurrence
Genital Diseases, Female
Tubulin Modulators
Ovarian Cancer
Endocrinopathy
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Ovarian Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gonadal Disorders
Epothilones
Mitosis Modulators
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Antimitotic Agents

Ovarian Diseases
Carboplatin
Pharmacologic Actions
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on September 01, 2009