Carboplatin, Paclitaxel, Bevacizumab and Vorinostat for Patients With Advanced Non-Small Cell Lung Cancer
Information source: Penn State University
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-Small Cell Lung Cancer
Intervention: Vorinostat, Bevacizumab, Carboplatin, Paclitaxel (Drug); Vorinostat, Bevacizumab, Carboplatin, Paclitaxel (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Penn State University Official(s) and/or principal investigator(s):
Chandra P Belani, MD, Principal Investigator, Affiliation: Penn State College of Medicine
Overall contact:
Chandra P. Belani, MD, Phone: 717-531-1078, Email: cbelani@psu.edu
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.
Clinical Details
Official title: Phase I Study of Carboplatin, Paclitaxel, Bevacizumab and Vorinostat for Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Study design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: 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.
Secondary outcome: 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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Chandra P. Belani, MD, Phone: 717-531-1078, Email: cbelani@psu.edu
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033, United States; Recruiting
Chandra P Belani, MD
Additional Information
Starting date: April 2008
Ending date: May 2012
Last updated: October 9, 2008
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