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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00325351
First received: May 11, 2006
Last updated: October 30, 2012
Last verified: October 2012
History of Changes
  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: Sagopilone (ZK 219477) + carboplatin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Drug Information available for: Carboplatin
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
Experimental: Arm 1 Drug: Sagopilone (ZK 219477) + 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
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
  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

Publications:

Responsible Party: Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00325351     History of Changes
Other Study ID Numbers: 91476, 307979
Study First Received: May 11, 2006
Last Updated: October 30, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Bayer:
Ovarian cancer
Ovarian neoplasms, epithelium

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

ClinicalTrials.gov processed this record on May 16, 2013