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

Penn State Health

Status and phase: Terminated; Phase 1

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Vorinostat, Bevacizumab, Carboplatin, Paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT00702572

PSHCI 08-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

1

Experimental group

Description:

Phase I dose escalating scheme

Treatment:

Drug: Vorinostat, Bevacizumab, Carboplatin, Paclitaxel

Drug: Vorinostat, Bevacizumab, Carboplatin, Paclitaxel

2

Experimental group

Description:

Phase 2 will evaluate the toxicities and safety profile of the 4-drug regimen.

Treatment:

Drug: Vorinostat, Bevacizumab, Carboplatin, Paclitaxel

Drug: Vorinostat, Bevacizumab, Carboplatin, Paclitaxel