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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01059552

Acronym

NSCLC

Enrollment

Registered

2010-02-01

Start date

2009-12-16

Completion date

2019-10-21

Last updated

2019-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Non-small Cell Lung Cancer

Keywords

lung cancer, locally advanced lung cancer

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.

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.

Interventions

DRUGvorinostat

vorinostat once daily for 12 weeks of therapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
To assess that safety and maximally tolerated dose of vorinostat in combination with chemoradiation for unresectable locally advanced NSCLC.	toxicity assessments will occur weekly

Secondary

Measure	Time frame
To investigate progression free survival.	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	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.	Archival tissue will be tested and correlated to response rates.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026