Treatment of Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
- Registration Number
- NCT01059552
- Lead Sponsor
- Fox Chase Cancer Center
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description vorinostat vorinostat Dose escalation of vorinostat, cisplatin, pemetrexed and radiation
- Primary Outcome Measures
Name Time Method To assess that safety and maximally tolerated dose of vorinostat in combination with chemoradiation for unresectable locally advanced NSCLC. toxicity assessments will occur weekly
- Secondary Outcome Measures
Name Time Method To investigate progression free survival. 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 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. Archival tissue will be tested and correlated to response rates.
Trial Locations
- Locations (3)
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States