BAY 43-9006 in Previously Untreated Patients With Non-Small Cell Lung Cancer (NSCLC)
The goal of this study is to find the highest tolerable dose of BAY 43-9006 (sorafenib) and bevacizumab that can be given with paclitaxel and carboplatin in patients with non-small cell lung cancer (NSCLC). The safety and effectiveness of this drug combination will also be studied.
Drug: BAY 43-9006
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Dose-Escalating, Open-Label, Non-Placebo Controlled Study of BAY 43-9006 (Sorafenib) in Combination With Carboplatin, Paclitaxel and Bevacizumab in Previously Untreated Patients With Stage IIIB (With Malignant Pleural Effusions) or Stage IV Non-Small Cell Lung Cancer (NSCLC)|
- Maximum Tolerated Dose (MTD) of BAY 43-9006 (sorafenib) and Bevacizumab in Combination with Carboplatin and Paclitaxel [ Time Frame: First day of every 21 day cycle ] [ Designated as safety issue: Yes ]If a dose limiting toxicity (DLT) occurs in ≥ 2 out of 6 patients at dose levels 2 - 6, dose escalation will be stopped and that dose will be declared the toxic dose. The dose level below will be declared the maximum tolerated dose if at this dose level 6 patients can be treated such that no more than 1 patient experiences a DLT.
|Study Start Date:||May 2006|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Experimental: BAY 43-9006 + Bevacizumab
BAY 43-9006 (Sorafenib) + Bevacizumab + Paclitaxel + Carboplatin
Drug: BAY 43-9006
Starting Dose of 200 mg orally twice a day on Day 3 through Day 19 of Cycle 1 and Days 2 through 19 of Cycle 2 and remaining cycles. Cycle is 21 days.
Other Name: SorafenibDrug: Paclitaxel
200 mg/m^2 By Vein Over 3 Hours on Day 1.
Other Name: TaxolDrug: Carboplatin
AUC 6 By Vein Over 30 Minutes on Day 1.
Other Name: ParaplatinDrug: Bevacizumab
Starting Dose of 5 mg/kg By Vein Over 90 minutes on Day 1.
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|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||George Blumenschein, MD||M.D. Anderson Cancer Center|