BAY 59-8862 in Treating Patients With Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who have non-small cell lung cancer.
|Study Design:||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:||March 2002|
|Primary Completion Date:||April 2003 (Final data collection date for primary outcome measure)|
- Determine the overall response rate, including partial and complete response, in patients with taxane-resistant non-small cell lung cancer treated with BAY 59-8862.
- Determine the overall survival of patients treated with this drug.
- Determine duration of response and time to progression in patients treated with this drug.
- Determine the quantitative and qualitative toxic effects of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive BAY 59-8862 IV over 1 hour on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients with responding disease receive 2-4 additional courses beyond maximal response.
Patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 14-84 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00054314
|Study Chair:||Nithya Ramnath, MD||Roswell Park Cancer Institute|