Treatment of Locally Advanced Non-Small Cell Lung Cancer (NSCLC) (NSCLC)
This study has been completed.
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: March 1, 2016
Last verified: March 2016
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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: | 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:
Genetics Home Reference 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 ] [ 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 ]
| Enrollment: | 18 |
| Study Start Date: | December 2009 |
| Primary Completion Date: | July 2015 (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) |
| 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
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, see Learn About Clinical Studies.
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 |
| Study First Received: | January 28, 2010 |
| Last Updated: | March 1, 2016 |
| Health Authority: | United States: Institutional Review Board |
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 30, 2016