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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Bayer |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00533585 |
Primary Objective:
-To define the safety profile and to determine the maximum tolerated dose (MTD) of BAY 43-9006 (sorafenib) and bevacizumab in combination with carboplatin and paclitaxel.
Secondary Objective:
-To evaluate the pharmacokinetics, pharmacodynamics and tumor response of patients treated with BAY 43-9006 (sorafenib) in combination with carboplatin, paclitaxel, and bevacizumab.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: BAY 43-9006 Drug: Paclitaxel Drug: Carboplatin Drug: Bevacizumab |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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) |
Estimated Enrollment: | 60 |
Study Start Date: | May 2006 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
BAY 43-9006 + Bevacizumab + Paclitaxel + Carboplatin
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Drug: BAY 43-9006
200 mg PO Twice Daily
Drug: Paclitaxel
200 mg/m^2 IV Over 3 Hours
Drug: Carboplatin
AUC 6 IV Over 30 Minutes
Drug: Bevacizumab
5 mg/kg Over 90 minutes
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
Contact: George Blumenschein, MD | 713-792-6363 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: George Blumenschein, MD |
Principal Investigator: | George Blumenschein, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( George Blumenschein, MD/Assistant Professor ) |
Study ID Numbers: | 2005-0818 |
Study First Received: | September 20, 2007 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00533585 |
Health Authority: | United States: Food and Drug Administration |
Non-Small Cell Lung Cancer Lung Cancer NSCLC malignant pleural effusions Sorafenib Paclitaxel |
Taxol Carboplatin Bevacizumab Avastin BAY 43-9006 |
Thoracic Neoplasms Non-small cell lung cancer Pleural Diseases Pleural Effusion, Malignant Carboplatin Bevacizumab Carcinoma Antibodies, Monoclonal Pleural Effusion Antibodies |
Respiratory Tract Diseases Lung Neoplasms Paclitaxel Lung Diseases Sorafenib Carcinoma, Non-Small-Cell Lung Immunoglobulins Neoplasms, Glandular and Epithelial Pleural Neoplasms |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Protein Kinase Inhibitors |
Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Phytogenic |