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Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00807573 |
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.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: Paclitaxel, pemetrexed and bevacizumab and Toxicity symptoms will be collected using the STAR system |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 44 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Maria Pietanza, MD | pietanzm@mskcc.org | |
Contact: Mark Kris, MD | krism@mskcc.org |
United States, New Jersey | |
Memorial Sloan-Kettering at Basking Ridge | Recruiting |
Basking Ridge, New Jersey, United States, 07920 | |
Contact: Maria Pietanza, MD pietanzm@mskcc.org | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Maria Pietanza, MD pietanzm@mskcc.org | |
Contact: Mark Kris, MD krism@mskcc.org | |
Principal Investigator: Maria Pietanza, MD | |
Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital | Recruiting |
Sleepy Hollow, New York, United States | |
Contact: Maria Pietanza, MD pietanzm@mskcc.org | |
Memorial Sloan-Kettering at Mercy Medical Center | Recruiting |
Rockville Centre, New York, United States | |
Contact: Maria Pietanza, MD pietanzm@mskcc.org | |
Memorial Sloan-Kettering Cancer Center @ Suffolk | Recruiting |
Commack, New York, United States, 11725 | |
Contact: Maria Pietanza, MD pietanzm@mskcc.org |
Principal Investigator: | Maria Pietanza, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Maria Pietanza, MD ) |
Study ID Numbers: | 08-109 |
Study First Received: | December 11, 2008 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00807573 |
Health Authority: | United States: Institutional Review Board |
BEVACIZUMAB (AVASTIN) PEMETREXED (ALTIMA) TAXOL (PACLITAXEL) |
Thoracic Neoplasms Disulfiram Non-small cell lung cancer Bevacizumab Carcinoma Pemetrexed Folic Acid |
Respiratory Tract Diseases Lung Neoplasms Paclitaxel Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Antimetabolites Respiratory Tract Neoplasms Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Mitosis Modulators Enzyme Inhibitors Antimitotic Agents |
Folic Acid Antagonists Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Phytogenic |