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

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Locally Advanced Non-small Cell Lung Cancer	Drug: vorinostat	Phase 1

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	18 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase I Study of the HDAC Inhibitor Vorinostat With Chemotherapy and Radiation Therapy for Treatment of Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
Actual Study Start Date :	December 16, 2009
Actual Primary Completion Date :	July 22, 2015
Estimated Study Completion Date :	December 1, 2018

Arms and Interventions

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Arm	Intervention/treatment
Experimental: vorinostat; Dose escalation of vorinostat, cisplatin, pemetrexed and radiation	Drug: vorinostat; vorinostat once daily for 12 weeks of therapy; Other Name: Zolinza

Outcome Measures

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Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. 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 ]
2. To evaluate response rates with this combination [ Time Frame: CT/PET will be done following 12 weeks of therapy. ]
3. 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. ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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 </= 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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Fox Chase Cancer Center

National Comprehensive Cancer Network

Investigators

Principal Investigator:	Ranee Mehra, MD	Fox Chase Cancer Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Fox Chase Cancer Center
ClinicalTrials.gov Identifier:	NCT01059552 History of Changes
Other Study ID Numbers:	FER-TH-031; NCI-2010-01913 ( Registry Identifier: NCI Clinical Trials Reporting Office )
First Posted:	February 1, 2010
Last Update Posted:	February 14, 2018
Last Verified:	February 2018

Keywords provided by Fox Chase Cancer Center:

lung cancer; locally advanced lung cancer

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases	Carcinoma, Bronchogenic; Bronchial Neoplasms; Vorinostat; Antineoplastic Agents; Histone Deacetylase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action