Treatment of Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

Temple University Health System (TUHS)

Status and phase

Completed

Phase 1

Conditions

Locally Advanced Non-small Cell Lung Cancer

Treatments

Drug: vorinostat

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT01059552

FER-TH-031

NCI-2010-01913 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 </= 2.5 X ULN.

Exclusion criteria

Chemotherapy or radiotherapy </= 4 weeks prior to registration (6 weeks for nitrosureas)
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