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Sponsors and Collaborators: |
Massachusetts General Hospital Dana-Farber Cancer Institute Abraxis BioScience Inc. Genentech |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00642759 |
The purpose of this research study is to learn more about whether the combination of drugs carboplatin, Abraxane and Avastin helps treat non-small cell lung cancer (NSCLC). One of the standard treatments for advanced NSCLC is the combination of the drugs carboplatin, paclitaxel and Avastin. Paclitaxel can be associated with severe side effects that may make the treatment difficult to tolerate. Some of these side effects are caused by the solution used to dissolve paclitaxel before it can be administered. Abraxane is a different form of paclitaxel that does not need to be dissolved by this solution. Abraxane is approved for the treatment of breast cancer but is not approved to treat NSCLC. We will also be trying to learn more about how the drug Avastin may work to treat cancer.
Condition | Intervention | Phase |
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Non-Small Cell Lung Cancer |
Drug: carboplatin Drug: Abraxane Drug: Avastin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Trial of Carboplatin, Abraxane, and Bevacizumab in Previously Untreated Patients With Advanced Non-Small Cell Lung Cancer |
Estimated Enrollment: | 36 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Participants can receive up to 6 cycles of carboplatin, Abraxane and Avastin if their disease does not get worse and they do not experience intolerable side effects.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rebecca Heist, MD MPH | 617-724-4000 | rheist@partners.org |
Contact: Patricia Ostler, RN | 617-724-7829 | postler@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Principal Investigator: Rebecca Heist, MD MPH | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: Leena Gandhi, MD, PhD |
Principal Investigator: | Rebecca Heist, MD MPH | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Rebecca Heist, MD MPH ) |
Study ID Numbers: | 07-339, ABX203-LC07US, AVF4298s |
Study First Received: | March 21, 2008 |
Last Updated: | November 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00642759 |
Health Authority: | United States: Institutional Review Board |
NSCLC Abraxane Carboplatin Bevacizumab Avastin |
Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Paclitaxel Lung Neoplasms Lung Diseases |
Carboplatin Bevacizumab Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Mitosis Modulators Antimitotic Agents Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Phytogenic |