Phase I Study of the HDAC Inhibitor Vorinostat With Chemotherapy and Radiation Therapy for Treatment of Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
18 Years
N/A
Both
Locally Advanced Non-small Cell Lung Cancer
Trial Information
Phase I Study of the HDAC Inhibitor Vorinostat With Chemotherapy and Radiation Therapy for Treatment of Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
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.
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
Exclusion Criteria:
- Chemotherapy or radiotherapy 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To assess that safety and maximally tolerated dose of vorinostat in combination with chemoradiation for unresectable locally advanced NSCLC.
Outcome Time Frame:
toxicity assessments will occur weekly
Safety Issue:
Yes
Principal Investigator
Ranee Mehra, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fox Chase Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
FER-TH-031
NCT ID:
NCT01059552
Start Date:
December 2009
Completion Date:
July 2013
Related Keywords:
- Locally Advanced Non-Small Cell Lung Cancer
- lung cancer
- locally advanced lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
| Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
| Moffitt Cancer Cetner | Tampa, Florida 33612 |
