Carboplatin, Paclitaxel, Bevacizumab and Vorinostat for Patients With Advanced Non-Small Cell Lung Cancer

Phase 1

Terminated

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Vorinostat, Bevacizumab, Carboplatin, Paclitaxel

• Registration Number: NCT00702572
• Lead Sponsor: Milton S. Hershey Medical Center

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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-06-19
• Study First Submitted QC: 2008-06-19
• Study First Posted: 2008-06-20
• Primary Completion: 2016-05
• Status Verified: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-21
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	Vorinostat, Bevacizumab, Carboplatin, Paclitaxel	Phase 2 will evaluate the toxicities and safety profile of the 4-drug regimen.
1	Vorinostat, Bevacizumab, Carboplatin, Paclitaxel	Phase I dose escalating scheme

Primary Outcome Measures

Name	Time	Method
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.	An average of 2 years	Participants will be followed for survival, an expected average of two years.

Secondary Outcome Measures

Name	Time	Method
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	Participants will be followed for survival, an expected average of 2 years.

Trial Locations

Locations (1)

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States