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Evaluation of BAY 59-8862 in Taxane Resistant Non-Small Cell Lung Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00044538
Recruitment Status : Completed
First Posted : September 4, 2002
Last Update Posted : June 22, 2009
Sponsor:
Information provided by:
Bayer

Brief Summary:
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 or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: BAY59-8862 (Cytotoxic Taxane) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : December 2001
Actual Study Completion Date : June 2004

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1 Drug: BAY59-8862 (Cytotoxic Taxane)
Intravenous dose over 60 minutes every 3 weeks





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00044538


Locations
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United States, Arizona
Tucson, Arizona, United States, 85712
United States, Connecticut
Waterbury, Connecticut, United States, 06708-2904
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Louisiana
Metairie, Louisiana, United States, 70006
United States, New York
Buffalo, New York, United States, 14263-0001
United States, Ohio
Columbus, Ohio, United States, 43235
United States, Tennessee
Nashville, Tennessee, United States, 37205
Canada, Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Hamilton, Ontario, Canada, L8V 5C2
Thunder Bay, Ontario, Canada, P7A 7T1
Canada, Quebec
Montreal, Quebec, Canada, H3T 1E2
Canada
Quebec, Canada, G1V 4G5
Germany
Gauting, Bayern, Germany, 82131
Berlin, Germany, 13353
Israel
Kfar Saba, Israel, 44281
Tel Aviv, Israel, 64239
Tel Hashomer, Israel, 52621
Italy
Modena, Italy, 41100
Parma, Italy, 43100
Pisa, Italy, 56126
Torino, Italy, 10126
Udine, Italy, 33100
Spain
Elche, Alicante, Spain, 03203
Barakaldo, Bizkaia, Spain, 48903
Barcelona, Spain, 08036
Madrid, Spain, 28034
Madrid, Spain, 28040
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00044538    
Other Study ID Numbers: 10653
First Posted: September 4, 2002    Key Record Dates
Last Update Posted: June 22, 2009
Last Verified: June 2009
Keywords provided by Bayer:
Taxane
Lung cancer, non-small cell
NSCLC
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Taxane
IDN 5109
Antineoplastic Agents