Lung Cancer Clinical Trial

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

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.

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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.

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Eligibility 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

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

18

Study ID:

NCT01059552

Recruitment Status:

Completed

Sponsor:

Fox Chase Cancer Center

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There are 3 Locations for this study

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Moffitt Cancer Center
Tampa Florida, 33612, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

18

Study ID:

NCT01059552

Recruitment Status:

Completed

Sponsor:


Fox Chase Cancer Center

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