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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of 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|
- Objective Response Rate (CR + PR by RECIST) Paclitaxel, Pemetrexed, and Bevacizumab in Patients With Advanced Non-Small Lung Cancer Who Have Received no Prior Treatment for Metastatic Disease. [ Time Frame: 2 years ] [ Designated as safety issue: No ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
|Study Start Date:||December 2008|
|Study Completion Date:||April 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Experimental: Paclitaxel, Bevacizumab & Pemetrexed
During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m^2 over 60 minutes on days 1 and 15. Pemetrexed 500mg/m^2 will be administered over 10 minutes on days 1 and 15. Bevacizumab will be given at 10mg/kg over 20 minutes on days 1 and 15
Day 1: Paclitaxel (90 mg/m^2 over 60 minutes) Day 15: Paclitaxel (90 mg/m^2 over 60 minutes)Drug: Pemetrexed
Day 1: Pemetrexed (500 mg/m^2 over 10 minutes) Day 15 Pemetrexed (500 mg/m2 over 10 minutes)Drug: Bevacizumab
Day 1:Bevacizumab (10 mg/kg over 20 minutes) Day 15: Bevacizumab (10 mg/kg over 20 minutes)
In this clinical trial, we also will be studying other things. We want to learn more about how to manage side effects patients may develop during chemotherapy. Cancer patients may develop side effects during treatment, such as nausea, pain, fatigue, diarrhea, constipation, or shortness of breath. These symptoms may be due to the cancer itself, or due to treatments like chemotherapy drugs or radiation therapy. Doctors and nurses often ask patients about their symptoms, because an important part of cancer treatment is to make patients feel as well as possible. If patients do not feel well, we may need to change the way we are treating them or prescribe therapies that will decrease their symptoms. The best way to find out how the patient is feeling is to ask them directly.
We are interested in developing new ways to ask patients about how they are feeling, using the Internet. A special new website called STAR ("Symptom Tracking and Reporting for Patients") has been developed to help patients record this information, so that their doctors and nurses can review it during clinic appointments. This study is designed to help us see if STAR is a helpful way for us to keep track of information about patients' symptoms and quality of life.
As part of this study, a computerized (automated) technique of determining the size of the patients tumor(s) before and after treatment will be used. This has been tested in the past and found to be more accurate. The automated technique of determining tumor size will be used with the routine CT scans that the patient will have as part of the study. This automated method of measuring the tumor(s) will allow us to know sooner whether this drug treatment is causing the disease to shrink.
The information from STAR and the automated tumor measurements are going to be placed on a very secure Internet site. This will provide the doctor with all of the information needed to determine if this drug combination is working for the patient and whether to continue this study.
Also, if there is a tumor sample from a biopsy done in the past, it will be analyzed for a protein that may be present in the lung cancer.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807573
|United States, New Jersey|
|Memorial Sloan-Kettering at Basking Ridge|
|Basking Ridge, New Jersey, United States, 07920|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center @ Suffolk|
|Commack, New York, United States, 11725|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Memorial Sloan-Kettering at Mercy Medical Center|
|Rockville Centre, New York, United States|
|Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital|
|Sleepy Hollow, New York, United States|
|Principal Investigator:||Maria Pietanza, MD||Memorial Sloan Kettering Cancer Center|