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

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ClinicalTrials.gov Identifier: NCT01059552
Recruitment Status : Completed
First Posted : February 1, 2010
Last Update Posted : November 27, 2019
Sponsor:
Collaborator:
National Comprehensive Cancer Network
Information provided by (Responsible Party):
Fox Chase Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Locally Advanced Non-small Cell Lung Cancer Drug: vorinostat Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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)
Actual Study Start Date : December 16, 2009
Actual Primary Completion Date : July 22, 2015
Actual Study Completion Date : October 21, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Vorinostat

Arms and Interventions
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Arm Intervention/treatment
Experimental: vorinostat
Dose escalation of vorinostat, cisplatin, pemetrexed and radiation
 Drug: vorinostat
vorinostat once daily for 12 weeks of therapy
Other Name: Zolinza


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. To evaluate response rates with this combination [ Time Frame: CT/PET will be done following 12 weeks of therapy. ]
  3. 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. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01059552


Locations
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United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Fox Chase Cancer Center
National Comprehensive Cancer Network
Investigators
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Principal Investigator: Ranee Mehra, MD Fox Chase Cancer Center
More Information
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Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT01059552    
Other Study ID Numbers: FER-TH-031
NCI-2010-01913 ( Registry Identifier: NCI Clinical Trials Reporting Office )
First Posted: February 1, 2010    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019
Keywords provided by Fox Chase Cancer Center:
lung cancer
locally advanced lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Vorinostat
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action