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

Completed · Phase 2

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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.

Key facts

Study ID

NCT00044538

Run by

Bayer

People needed

102

Starts

2001-12-01

Expected to finish

2004-06-01

Last updated by the study team

2009-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Waterbury, Connecticut, United States
• Study site — Louisville, Kentucky, United States
• Study site — Metairie, Louisiana, United States
• Study site — Buffalo, New York, United States
• Study site — Columbus, Ohio, United States
• Study site — Nashville, Tennessee, United States
• Study site — Edmonton, Alberta, Canada
• Study site — Hamilton, Ontario, Canada
• Study site — Thunder Bay, Ontario, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Québec, Quebec, Canada
• Study site — Gauting, Bavaria, Germany
• Study site — Berlin, State of Berlin, Germany
• Study site — Kfar Saba, Israel
• Study site — Tel Aviv, Israel
• Study site — Tel Litwinsky, Israel
• Study site — Modena, Italy
• Study site — Parma, Italy
• Study site — Pisa, Italy
• Study site — Torino, Italy
• Study site — Udine, Italy
• Study site — Elche, Alicante, Spain
• Study site — Barcelona, Barcelona, Spain
• Study site — Barakaldo, Bizkaia, Spain

Full record on ClinicalTrials.gov

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