Treatment of Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
Conditions
Locally Advanced Non-small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
lung cancer, locally advanced lung cancer
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: vorinostat
Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to determine the maximum tolerated dose of the combination of vorinostat, cisplatin, pemetrexed, and radiation therapy in patients with unresectable stage IIIA/IIIB non-small cell lung cancer.
Detailed Description
This phase I trial will escalate doses of the histone deacetylase inhibitor (HDAC) vorinostat to a chemoradiation platform for cisplatin, pemetrexed and radiation to a dose of 70Gy in NSCLC patients with unresectable IIIA and dry IIIB disease. The endpoint will be to determine MTD of the combination.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- biopsy proven non-squamous NSCLC with unresectable stage IIIA or dry IIIB disease.

- FEV1 >/= 1 liter

- ECOG PS 0 or 1

- Able to swallow and absorb enterally

- Measurable disease per RECIST 1.1

- Adequate organ and marrow function including calculated creatinine clearance >/= 60 mL/min hepatic enzymes and alk phos
Exclusion Criteria:

- Chemotherapy or radiotherapy
- Active bleeding

- Known brain mets

- Prior thoracic radiotherapy that would lead to overlap with current radiation field.

- More than 10% weight loss in 6 months.

- Pancoast tumors, supraclavicular or contralateral hilar lymph node involvement

- Known HIV positive

- Prior treatment with an HDAC inhibitor
Locations
Moffitt Cancer Center
Tampa, Florida, United States
Status: Recruiting
Contact: Mary Pinder, MD - Mary.Pinder@moffitt.org
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Status: Recruiting
Medical University of South Carolina
Charleston, South Carolina, United States
Status: Recruiting
Contact: Shanta Salzer - 843-792-1463 - salzers@musc.edu
Start Date
December 2009
Sponsors
Fox Chase Cancer Center
Source
Fox Chase Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page