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Home > "E" Clinical Trials Conditions > Evaluation of Bay 59-8862 in Taxane-Resistant Metastatic Breast Cancer Patients  Evaluation of Bay 59-8862 in Taxane-Resistant Metastatic Breast Cancer Patients
Evaluation of Bay 59-8862 in Taxane-Resistant Metastatic Breast Cancer Patients
For Condition: Breast Neoplasms,Metastases, Neoplasm
Status: Terminated
Sponsor(s): Bayer Corporation ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry 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.
Total Enrollment: 84
Location and Contact Information:
Hematology Oncology Consultants
Columbus, Ohio, 43235
United States
Norton Healthcare Pavillion
Louisville, Kentucky, 40202
United States
University of Florida - Jacksonville
Jacksonville, Florida, 32209
United States
Mid-Ohio Oncology/Hematology
Columbus, Ohio, 43213
United States
Medical Oncology/Hematology
Meriden, Connecticut, 06450
United States
Pennsylvania Onc./Hem. Assoc.
Philadelphia, Pennsylvania, 19106
United States
Additional Information:
Study ID Numbers: Protocol No. 10654;
Study Start Date: April 2002
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00044525
Other Breast Neoplasms Studies:
1. Study of Temozolomide in the Treatment of Brain Metastasis from Non-small-cell Lung Cancer
2. Study of ABI-007 and Taxol in Patients with Metastatic Breast Cancer
3. Assessment of Head and Neck Tumor Hypoxia Using 18F-Fluoromisonidazole
4. A Phase II Clinical Trial of ABI-007, Administered Weekly in Taxol Resistant Patients with Metastatic Breast Cancer
5. A Trial of ABI-007 in Patients with Advanced Non-Hematologic Malignancies
Related Studies:
Other Breast Neoplasms Clinical Trials
Other Ohio Clinical Trials
Other Columbus Clinical Trials
Evaluation of Bay 59-8862 in Taxane-Resistant Metastatic Breast Cancer Patients
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