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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
vorinostat once daily for 12 weeks of therapy
Moffitt Cancer Center
Tampa, Florida, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
To assess that safety and maximally tolerated dose of vorinostat in combination with chemoradiation for unresectable locally advanced NSCLC.
Time frame: toxicity assessments will occur weekly
To investigate progression free survival.
Time frame: CT/PET scans will be done after 12 weeks of therapy and at 12 week intervals until documented progression
To evaluate response rates with this combination
Time frame: CT/PET will be done following 12 weeks of therapy.
To assess if pre-treatment tumor expression of TS, ERCC1 and HDAC1, 2, 3 are associated with response rate.
Time frame: Archival tissue will be tested and correlated to response rates.
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