Treatment of Locally Advanced Non-Small Cell Lung Cancer (NSCLC) (NSCLC)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01059552 |
Recruitment Status :
Completed
First Posted : February 1, 2010
Last Update Posted : November 27, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Locally Advanced Non-small Cell Lung Cancer | Drug: vorinostat | Phase 1 |
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 |

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 |
- 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 ]
- 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 ]
- To evaluate response rates with this combination [ Time Frame: CT/PET will be done following 12 weeks of therapy. ]
- 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. ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Principal Investigator: | Ranee Mehra, MD | Fox Chase Cancer Center |
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 |
lung cancer locally advanced lung cancer |
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 |