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Treatment of Locally Advanced Non-Small Cell Lung Cancer (NSCLC) (NSCLC)
This study is ongoing, but not recruiting participants.
Sponsor:
Fox Chase Cancer Center
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: January 24, 2017
Last verified: January 2017
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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: | 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
lung cancer
MedlinePlus related topics:
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 ]
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 ]
- 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. ]
| Enrollment: | 18 |
| Actual Study Start Date: | December 6, 2009 |
| Estimated Study Completion Date: | December 1, 2017 |
| Estimated Primary Completion Date: | December 1, 2017 (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 (Adult, Senior) |
| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01059552
Please refer to this study by its ClinicalTrials.gov identifier: NCT01059552
Locations
| 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
| Principal Investigator: | Ranee Mehra, MD | Fox Chase Cancer Center |
More Information
| Responsible Party: | Fox Chase Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01059552 History of Changes |
| Other Study ID Numbers: |
FER-TH-031 NCI-2010-01913 ( Registry Identifier: NCI Clinical Trials Reporting Office ) |
| Study First Received: | January 28, 2010 |
| Last Updated: | January 24, 2017 |
Keywords provided by Fox Chase Cancer Center:
|
lung cancer locally advanced lung cancer |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on September 20, 2017