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

This study is currently recruiting participants.

Verified October 2012 by Fox Chase Cancer Center

Sponsor:

Collaborator:

National Comprehensive Cancer Network

Information provided by (Responsible Party):

Fox Chase Cancer Center

ClinicalTrials.gov Identifier:

NCT01059552

First received: January 28, 2010

Last updated: October 3, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 28, 2010

Last Updated Date

October 3, 2012

Start Date ^ICMJE

December 2009

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01059552 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]
To evaluate response rates with this combination [ Time Frame: CT/PET will be done following 12 weeks of therapy. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Locally Advanced Non-small Cell Lung Cancer

Intervention ^ICMJE

Drug: vorinostat

vorinostat once daily for 12 weeks of therapy

Other Name: Zolinza

Study Arm (s)

Experimental: vorinostat

Dose escalation of vorinostat, cisplatin, pemetrexed and radiation

Intervention: Drug: vorinostat

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2013

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ranee Mehra, MD	215-728-2985	ranee.mehra@fccc.edu
Contact: Holly Tuttle, MSN	215-728-2451	holly.tuttle@fccc.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01059552

Other Study ID Numbers ^ICMJE

FER-TH-031, NCI-2010-01913

Has Data Monitoring Committee

Yes

Responsible Party

Fox Chase Cancer Center

Study Sponsor ^ICMJE

Fox Chase Cancer Center

Collaborators ^ICMJE

National Comprehensive Cancer Network

Investigators ^ICMJE

Principal Investigator:

Ranee Mehra, MD

Fox Chase Cancer Center

Information Provided By

Fox Chase Cancer Center

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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