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

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.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* Pathologically confirmed Non-Small Cell Lung Cancer at MSKCC
* Clinical stage IIIB or IV.
* Measurable disease as per RECIST
* Greater than 6 months since receiving neo-adjuvant or adjuvant chemotherapy for Non-Small Cell Lung Cancer.
* Age ≥ 18 years.
* Karnofsky performance status of ≥ to 70.
* Marrow and organ function as follows:
* WBC ≥ to 4000/mm3
* Platelets ≥ to 160,000
* Bilirubin ≤ to 1.2mg/dL
* Creatinine clearance ≥ to 40mL/min
* AST and/or /ALT ≤ 37 Units/L (if one of these elevated, must be ≤ 2.5 ULN)
* Systolic blood pressure ≤ to 150mmHg or diastolic blood pressure ≤ to 100 mmHg).
* The subject is able to read and comprehend English text from a computer screen.
* Women of childbearing potential and sexually active men enrolled in the study must agree to practice effective contraception.

Exclusion Criteria:

* Squamous cell carcinoma.
* Prior treatment with paclitaxel, pemetrexed or bevacizumab for NSCLC.
* Prior systemic anticancer therapy for advanced NSCLC.
* Symptomatic brain metastases with evidence of hemorrhage.
* Radiation therapy to greater than 25% of the bone marrow within 30 days of starting treatment.
* Peripheral neuropathy greater than grade 1.
* Malignancies within the past 5 years other than non-melanoma skin cancer.
* Patients with other serious medical illnesses including, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
* History of hemoptysis.
* History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess.
* History of myocardial infarction or stroke within 6 months prior to enrollment.
* Pregnancy or lactation.

• DERIVEDBasch 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. PMID 26542025
• DERIVEDPietanza 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. PMID 23630218