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

Locally Advanced Non-small Cell Lung Cancer Clinical Trial

— NSCLC  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01059552
• Other study ID #: FER-TH-031
• Secondary ID: NCI-2010-01913
• Status: Completed
• Phase: Phase 1
• Start date: December 16, 2009
• Est. completion date: October 21, 2019

Study information

• Verified date: November 2019
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 21, 2019
• Est. primary completion date: July 22, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Locally Advanced Non-small Cell Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• vorinostat
vorinostat once daily for 12 weeks of therapy

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Fox Chase Cancer Center	National Comprehensive Cancer Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To investigate progression free survival.		CT/PET scans will be done after 12 weeks of therapy and at 12 week intervals until documented progression
Secondary	To evaluate response rates with this combination		CT/PET will be done following 12 weeks of therapy.
Secondary	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.