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

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ClinicalTrials.gov Identifier: NCT00325351
Recruitment Status : Completed
First Posted : May 12, 2006
Last Update Posted : November 3, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

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 Type : Interventional  (Clinical Trial)
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
Study Start Date : August 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Carboplatin

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




Primary Outcome Measures :
  1. Response to treatment with ZK-Epo after 6 cycles [ Time Frame: After 6 cycles ]

Secondary Outcome Measures :
  1. Safety and tolerability of ZK-Epo given with carboplatin [ Time Frame: Sept. 2008 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
La Jolla, California, United States, 92093
San Diego, California, United States, 92121
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
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

Additional Information:
Publications of Results:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00325351     History of Changes
Other Study ID Numbers: 91476
307979 ( Other Identifier: company internal )
First Posted: May 12, 2006    Key Record Dates
Last Update Posted: November 3, 2014
Last Verified: October 2014

Keywords provided by Bayer:
Ovarian cancer
Ovarian neoplasms, epithelium

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carboplatin
Antineoplastic Agents