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Completed

NCT Number: NCT01059552

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

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.

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Key information

Conditions

Locally Advanced Non-Small Cell Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Moffitt Cancer Center, Tampa, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vorinostat

Drug

vorinostat once daily for 12 weeks of therapy

Other names: Zolinza

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Fox Chase Cancer Center

Other

Collaborators

  • National Comprehensive Cancer Network

Registry information

Official study 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)

Acronym: NSCLC

Important dates

Study start
2009
Primary completion
2015
Study completion
2019
First posted
Feb 1, 2010
Registry last updated
Nov 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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