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Evaluation of Bay 59-8862 in Taxane-Resistant Metastatic Breast Cancer Patients
This study has been completed.
Sponsored by: Bayer
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00044525
  Purpose

Breast cancer is the most common form of cancer among women in developing countries, accounting for approximately one-fifth of all female cancers in the United States. Although mortality rates are declining in some countries, it remains the leading cause of death in women aged 40-55 years. The median survival for women with metastatic breast cancer is 2-3 years but there is significant variability in this population. The primary goals of treatment in patients with metastatic breast cancer are improvement or maintenance of quality of life and prolongation of survival. The taxanes, paclitaxel and docetaxel, were incorporated into the treatment of metastatic breast cancer in the 1990's. The usefulness of the taxanes is limited by the development of tumor resistance to these agents. This phase II trial with BAY 59-8862 will be conducted to determine the anti-tumor efficacy of BAY 59-8862 in taxane-resistant metastatic breast cancer.


Condition Intervention Phase
Breast Neoplasms
Metastases, Neoplasm
Drug: Bay 59-8862
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: An Uncontrolled Phase II Study Evaluating the Efficacy and Safety of Intravenous BAY 59-8862 in Patients With Taxane-Resistant Metastatic Breast Cancer

Further study details as provided by Bayer:

Estimated Enrollment: 84
Study Start Date: April 2002
  Eligibility

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

Inclusion Criteria:

  • female patients with a proven diagnosis of metastatic breast cancer
  • measurable disease as defined by the presence of at least one measurable lesion
  • patients must have received at least 3 weeks of continuous therapy with Taxane - patient must subsequently develop progressive disease either during treatment or within 6 months after treatment
  • patients who failed on hormone therapy
  • life expectancy of at least 12 weeks.
  • adequate bone marrow, liver and kidney function
  • patients with active brain metastases may be included

Exclusion Criteria:

  • excluded medical conditions like : pre-existing neuropathy, active heart diseases or ischemia; surgery within 4 weeks of study entry; serious infections; HIV infection; chronic hepatitis B or C; patients with brain metastases must be without a seizure; hypersensitivity to taxanes; organ transplants; some previous cancers
  • excluded therapies and medications, previous and concomitant such as: anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to study entry; more than two prior anticancer chemotherapy regimens; radiotherapy during study or within 4 weeks prior to study entry; bone marrow transplant
  • others: pregnant or breast-feeding patients; women enrolled in this trial must use adequate barrier birth control measures during the course of the trial; substance abuse, medical, psychological or social conditions that may interfere with the patient's participation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00044525

Locations
United States, Connecticut
Medical Oncology/Hematology
Meriden, Connecticut, United States, 06450
United States, Florida
University of Florida - Jacksonville
Jacksonville, Florida, United States, 32209
United States, Kentucky
Norton Healthcare Pavillion
Louisville, Kentucky, United States, 40202
United States, Ohio
Mid-Ohio Oncology/Hematology
Columbus, Ohio, United States, 43213
Hematology Oncology Consultants
Columbus, Ohio, United States, 43235
United States, Pennsylvania
Pennsylvania Onc./Hem. Assoc.
Philadelphia, Pennsylvania, United States, 19106
Sponsors and Collaborators
Bayer
  More Information

Study ID Numbers: Protocol No. 10654
Study First Received: August 30, 2002
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00044525  
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Taxane
Breast Cancer
Metastasis

Study placed in the following topic categories:
Skin Diseases
Neoplasm Metastasis
Breast Neoplasms
Taxane
Breast Diseases

Additional relevant MeSH terms:
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009