Paclitaxel, Bevacizumab and Pemetrexed in Patients With Untreated, Advanced Non-Small Cell Lung Cancer Using Web-Based Data Collection, Patient Self-Reporting of Adverse Effects and Automated Response Assessment

Summary

The purpose of this study is to determine the percentage of patients with non-small cell lung cancer that will experience a shrinkage of their tumors following treatment with three medications given together: paclitaxel, pemetrexed (Alimta®), and bevacizumab (Avastin®). Each of these medications has been approved by the FDA for patients that have not received any treatment for their lung cancer. This study is designed to study the effects of all three drugs given at the same time. Each of these medications has been studied in lung cancer and is commercially available. Paclitaxel and pemetrexed are traditional chemotherapy drugs. Bevacizumab is a monoclonal antibody, which means that it attaches to a specific target. Bevacizumab attaches to a protein in the blood stream called Vascular Endothelial GrowthFactor (VEGF). VEGF helps tumors grow new blood vessels to feed themselves, and bevacizumab is thought to help block this new growth of blood vessels and starve the tumors of the nutrients they need.

Timeline

Start

2008-12

Primary completion

2014-04

Completion

2014-04

Publications

• Basch E, Wood WA, Schrag D, Sima CS, Shaw M, Rogak LJ, Kris MG, Shouery M, Bennett A, Atkinson T, Pietanza MC. Feasibility and clinical impact of sharing patient-reported symptom toxicities and performance status with clinical investigators during a phase 2 cancer treatment trial. Clin Trials. 2016 Jun;13(3):331-7. doi: 10.1177/1740774515615540. Epub 2015 Nov 4.
• Pietanza MC, Basch EM, Lash A, Schwartz LH, Ginsberg MS, Zhao B, Shouery M, Shaw M, Rogak LJ, Wilson M, Gabow A, Latif M, Lin KH, Wu Q, Kass SL, Miller CP, Tyson L, Sumner DK, Berkowitz-Hergianto A, Sima CS, Kris MG. Harnessing technology to improve clinical trials: study of real-time informatics to collect data, toxicities, image response assessments, and patient-reported outcomes in a phase II clinical trial. J Clin Oncol. 2013 Jun 1;31(16):2004-9. doi: 10.1200/JCO.2012.45.8117. Epub 2013 Apr 29.

Drugs

Indications