BAY 43-9006 in Previously Untreated Patients With Non-Small Cell Lung Cancer (NSCLC)
|ClinicalTrials.gov Identifier: NCT00533585|
Recruitment Status : Completed
First Posted : September 21, 2007
Last Update Posted : February 10, 2016
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: BAY 43-9006 Drug: Paclitaxel Drug: Carboplatin Drug: Bevacizumab||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
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
Area under curve (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.
- 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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00533585
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||George Blumenschein, MD||M.D. Anderson Cancer Center|