Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatments vorinostat, bevacizumab, carboplatin, paclitaxel
Phase phase 1
Sponsor Milton S. Hershey Medical Center
Start date April 2008
End date May 2016
Trial size 25 participants
Trial identifier NCT00702572, PSHCI 08-004

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Phase I dose escalating scheme
vorinostat, bevacizumab, carboplatin, paclitaxel SAHA
This dose escalating phase will enroll sequential cohorts of 3-6 patients to be entered at the following dose levels: Level -1: Days 1-14, Vorinostat 100 mg po QD; Day 3, Bevacizumab 15 mg/kg; Carboplatin 6 AUC; Paclitaxel 175 mg/m2. Level 1: Days 1-14, Vorinostat 200 mg po QD days 1-14; Day 3, Bevacizumab 15 mg/kg; Carboplatin 6 AUC; Paclitaxel 200 mg/m2. Level 2: Days 1-14, Vorinostat 300 mg po QD days 1-14; Day 3, Bevacizumab 15 mg/kg; Carboplatin 6 AUC; Paclitaxel 200 mg/m2. Level 3: Days 1-14, Vorinostat 400 mg po QD days 1-14; Day 3, Bevacizumab 15 mg/kg; Carboplatin 6 AUC; Paclitaxel 200 mg/m2. Treatment cycles will be repeated every 3 weeks. The highest dose level which <2 out of 5 patients experience dose limiting toxicity will be defined as the recommended phase II dose.
(Experimental)
Phase 2 will evaluate the toxicities and safety profile of the 4-drug regimen.
vorinostat, bevacizumab, carboplatin, paclitaxel SAHA
Once the recommended phase II dose has been established from Phase I, 12 additional patients will be treated to evaluate the toxicities and safety profile of the 4-drug regimen.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Milton S. Hershey Medical Center.