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Evaluation of Bay 59-8862 in Taxane Resistant Non-Small Cell Lung Cancer Patients
This study has been completed.
Sponsored by: Bayer
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00044538
  Purpose

Lung cancer is among the most common cancers in the world and its incidence continues to increase. Chemotherapy for patients with Non-Small Cell Lung Cancer (NSCLC) has been under investigation for several decades and several new drugs with activity in NSCLC have been identified. These include the taxanes, which are among the most commonly used class of chemotherapy agents in clinical oncology today. 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 NSCLC.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: Bay 59-8862
Phase II

MedlinePlus related topics: Cancer Lung 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 Anti-Tumor Efficacy and Safety of BAY 59-8862 in Patients With Taxane Resistant Non-Small Cell Lung Carcinoma (NSCLC)

Further study details as provided by Bayer:

Estimated Enrollment: 84
Study Start Date: December 2001
  Eligibility

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

Inclusion Criteria:

  • 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
  • life expectancy of at least 12 weeks
  • adequate bone marrow, liver and kidney function

Exclusion Criteria:

  • excluded medical conditions like: pre-existing neuropathy, active heart diseases or ischemia, serious infections, HIV infection, chronic hepatitis B or C; brain metastasis, seizures, 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; both men and 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: NCT00044538

Locations
United States, Connecticut
Medical Oncology/Hematology
Meriden, Connecticut, United States, 06450
United States, Kentucky
Norton Healthcare Pavillion
Louisville, Kentucky, United States, 40202
United States, Louisiana
Jayne Gurtler APMC
Metairie, Louisiana, United States, 70006
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, Ohio
Hematology Oncology Consultants
Columbus, Ohio, United States, 43235
United States, South Carolina
Spartanburg Reg. Hlth. Care Sys.
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Tennessee Oncology, PC
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Bayer
  More Information

Study ID Numbers: Protocol No. 10653
Study First Received: August 30, 2002
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00044538  
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Taxane
lung cancer, non-small cell
NSCLC

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Taxane
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009