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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
  Purpose

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.


Condition Intervention Phase
Locally Advanced Non-small Cell Lung Cancer
 Drug: vorinostat
 Phase 1

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Vorinostat
U.S. FDA Resources

Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 22
Study Start Date: December 2009
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vorinostat
Dose escalation of vorinostat, cisplatin, pemetrexed and radiation
 Drug: vorinostat
vorinostat once daily for 12 weeks of therapy
Other Name: Zolinza

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01059552

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

Locations
United States, Florida
Moffitt Cancer Cetner Recruiting
Tampa, Florida, United States, 33612
Contact: Anglea Tolemeo     813-745-4625     angela.tolomeo@moffitt.org    
Contact: Mary Pinder, MD         Mary.Pinder@moffitt.org    
Principal Investigator: Mary Pinder, MD            
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Marianne Bonner, RN, BSN     215-728-2769     marianne.bonner@fccc.edu    
Principal Investigator: Ranee Mehra, MD            
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Shanta Salzer     843-792-1463     salzers@musc.edu    
Contact: Keisuke Shirai, MD, MSCR     843-792-8584     shirai@musc.edu    
Principal Investigator: Keisuke Shirai, MD            
Sponsors and Collaborators
Fox Chase Cancer Center
National Comprehensive Cancer Network
Investigators
Principal Investigator: Ranee Mehra, MD Fox Chase Cancer Center
  More Information

No publications provided

Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT01059552     History of Changes
Other Study ID Numbers: FER-TH-031, NCI-2010-01913
Study First Received: January 28, 2010
Last Updated: October 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Fox Chase Cancer Center:
lung cancer
locally advanced lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
 Respiratory Tract Diseases
Vorinostat
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013