Evaluation of BAY59-8862 in Taxane-Resistant Metastatic Breast Cancer Patients

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00044525
First received: August 30, 2002
Last updated: April 19, 2010
Last verified: April 2010
  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 BAY59-8862 will be conducted to determine the anti-tumor efficacy of BAY59-8862 in taxane-resistant metastatic breast cancer.


Condition Intervention Phase
Breast Neoplasms
Breast Cancer, Metastatic
Drug: BAY59-8862 (Cytotoxic Taxane)
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: An Uncontrolled Phase II Study Evaluating the Efficacy and Safety of Intravenous BAY59-8862 in Patients With Taxane-Resistant Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Bayer:

Enrollment: 84
Study Start Date: April 2002
Study Completion Date: February 2004
Arms Assigned Interventions
Experimental: Arm 1 Drug: BAY59-8862 (Cytotoxic Taxane)
1 h intravenous infusion every 3 weeks

  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
Germany
Stuttgart, Baden-Württemberg, Germany, 70376
Jena, Thüringen, Germany, 07740
Berlin, Germany, 10117
Greece
Maroussi, Attica, Greece, 15123
Heraklion, Creta, Greece, 711 10
Israel
Ashkelon, Israel, 78306
Haifa, Israel, 31096
Tel Aviv, Israel, 64239
Tel Hashomer, Israel, 52621
Italy
Treviglio, Bergamo, Italy, 24047
Rozzano, Milano, Italy, 20089
Biella, Italy, 13900
Cuneo, Italy, 12100
Forlì, Italy, 47100
Parma, Italy, 43100
Udine, Italy, 33100
Poland
Olsztyn, Poland, 10-228
Warszawa, Poland, 02-781
Warszawa, Poland, 00-909
Switzerland
Aarau, Aargau, Switzerland, 5001
United Kingdom
London, Greater London, United Kingdom, SW3 6JJ
London, Greater London, United Kingdom, NW3 2QG
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00044525     History of Changes
Other Study ID Numbers: 10654
Study First Received: August 30, 2002
Last Updated: April 19, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Taxane
Breast Cancer
Metastasis

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Taxane
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014