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

Status:	Active, not recruiting
Conditions:	Lung Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	2/16/2018
Start Date:	December 16, 2009
End Date:	December 1, 2018

Phase I Study of the HDAC Inhibitor Vorinostat With Chemotherapy and Radiation Therapy for Treatment of Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

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.

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.

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 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

We found this trial at

sites

Fox Chase Cancer Center

Philadelphia, Pennsylvania 19111

from

Philadelphia, PA