Treatment of Locally Advanced Non-Small Cell Lung Cancer... | NCT01059552

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

NCT01059552

Sponsor

Fox Chase Cancer Center

Status

Completed

Last Update Posted

Nov 27, 2019Actual

Enrollment

18Actual

Phase

Phase 1

Conditions

Locally Advanced Non-small Cell Lung Cancer

Interventions

vorinostat

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2010-01913	Registry Identifier	NCI Clinical Trials Reporting Office

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 16, 2009Actual

Primary Completion Date

Jul 22, 2015Actual

Completion Date

Oct 21, 2019Actual

First Submitted Date

Jan 28, 2010

First Submission Date that Met QC Criteria

Jan 29, 2010

First Posted Date

Feb 1, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2019

Last Update Posted Date

Nov 27, 2019Actual

Name	Class
National Comprehensive Cancer Network	NETWORK

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
vorinostat	Experimental	Dose escalation of vorinostat, cisplatin, pemetrexed and radiation	Drug: vorinostat

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vorinostat	Drug	vorinostat once daily for 12 weeks of therapy	vorinostat

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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 \

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ranee Mehra, MD	Fox Chase Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Moffitt Cancer Center		Tampa	Florida	33612	United States
Fox Chase Cancer Center

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077337	Vorinostat

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided