Phase I Study of Carboplatin, Paclitaxel, Bevacizumab and Vorinostat for Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Overview
- Phase
- Phase 1
- Intervention
- Vorinostat, Bevacizumab, Carboplatin, Paclitaxel
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- Milton S. Hershey Medical Center
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Chandra P. Belani
Professor of Medicine
Milton S. Hershey Medical Center
Eligibility Criteria
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
Arms & Interventions
1
Phase I dose escalating scheme
Intervention: Vorinostat, Bevacizumab, Carboplatin, Paclitaxel
2
Phase 2 will evaluate the toxicities and safety profile of the 4-drug regimen.
Intervention: Vorinostat, Bevacizumab, Carboplatin, Paclitaxel
Outcomes
Primary Outcomes
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
Participants will be followed for survival, an expected average of two years.
Secondary Outcomes
- 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.(Average of 2 years)