Carboplatin, Paclitaxel, Bevacizumab and Vorinostat for Patients With Advanced Non-Small Cell Lung Cancer
This trial is active, not recruiting.
|Condition||non-small cell lung cancer|
|Treatments||vorinostat, bevacizumab, carboplatin, paclitaxel|
|Sponsor||Milton S. Hershey Medical Center|
|Start date||April 2008|
|End date||May 2016|
|Trial size||25 participants|
|Trial identifier||NCT00702572, PSHCI 08-004|
The primary objective of the study is to establish the phase II recommended dose of Vorinostat when administered in combination with the regimen of carboplatin, paclitaxel and bevacizumab for patients with previously untreated advanced non-small cell lunc cancer.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Establish the phase II recommended dose (P2RD) of Vorinostat when administered in combination with the regimen of carboplatin, paclitaxel and bevacizumab for patients with previously untreated advanced non-small cell lung cancer.
time frame: An average of 2 years
Evaluate safety profile of 4-drug regimen. Obtain preliminary evidence regarding anti-cancer activity of the regimen. Understand mechanistic aspects of drug effect by conducting correlative science studies on peripheral blood and archived tumor tissue.
time frame: Average of 2 years
Male or female participants at least 18 years old.
Inclusion Criteria: - Advanced non-squamous NSCLC - No prior chemotherapy for advanced disease - ECOG performance status 0 or 1 - Measurable disease - Life expectancy > 3 months - Normal bone marrow, renal and hepatic function - Ability to take oral medications - Willingness to sign informed consent Exclusion Criteria: - History of brain metastasis - Evidence of thromboembolic phenomenon and treatment with anticoagulants - Pregnancy - Uncontrolled inter-current illness - Prior therapy with Paclitaxel
|Official title||Phase I Study of Carboplatin, Paclitaxel, Bevacizumab and Vorinostat for Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)|
|Principal investigator||Chandra P Belani, MD|
|Description||Since the regimen of bevacizumab, carboplatin and paclitaxel has become a standard regimen for the treatment of advanced non-squamous NSCLC, new studies in this patient population will have to include this as a reference arm. Addition of a fourth anti-cancer agent has now become the new strategy to improve the outcome for advanced non-squamous NSCLC. Since the regimen of Vorinostat, Carboplatin and Paclitaxel is already in advanced stage of development it is important to study the safety and tolerability of Vorinostat in combination with the three-drug regimen of Bevacizumab, Carboplatin and Paclitaxel. Therefore, we will evaluate Vorinostat when administered in combination with the regimen of Carboplatin, Paclitaxel and Bevacizumab for patients with previously untreated advanced non-small cell lung cancer.|
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