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

Primary Purpose

Locally Advanced Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
vorinostat
Sponsored by
Fox Chase Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Non-small Cell Lung Cancer focused on measuring lung cancer, locally advanced lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Moffitt Cancer Center
  • Fox Chase Cancer Center
  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

vorinostat

Arm Description

Dose escalation of vorinostat, cisplatin, pemetrexed and radiation

Outcomes

Primary Outcome Measures

To assess that safety and maximally tolerated dose of vorinostat in combination with chemoradiation for unresectable locally advanced NSCLC.

Secondary Outcome Measures

To investigate progression free survival.
To evaluate response rates with this combination
To assess if pre-treatment tumor expression of TS, ERCC1 and HDAC1, 2, 3 are associated with response rate.

Full Information

First Posted
January 28, 2010
Last Updated
November 26, 2019
Sponsor
Fox Chase Cancer Center
Collaborators
National Comprehensive Cancer Network
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1. Study Identification

Unique Protocol Identification Number
NCT01059552
Brief Title
Treatment of Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 16, 2009 (Actual)
Primary Completion Date
July 22, 2015 (Actual)
Study Completion Date
October 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fox Chase Cancer Center
Collaborators
National Comprehensive Cancer Network

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Non-small Cell Lung Cancer
Keywords
lung cancer, locally advanced lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vorinostat
Arm Type
Experimental
Arm Description
Dose escalation of vorinostat, cisplatin, pemetrexed and radiation
Intervention Type
Drug
Intervention Name(s)
vorinostat
Other Intervention Name(s)
Zolinza
Intervention Description
vorinostat once daily for 12 weeks of therapy
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
To evaluate response rates with this combination
Time Frame
CT/PET will be done following 12 weeks of therapy.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 </= 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ranee Mehra, MD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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