TUSC2-nanoparticles and Erlotinib in Stage IV Lung Cancer
Summary
The goal of phase 1 of this clinical research study is to find the highest dose of DOTAP:Chol-TUSC2 that can be safely given in combination with Tarceva (erlotinib hydrochloride) to patients with NSCLC. The goal of phase 2 of this clinical research study is to learn if the combination of DOTAP:Chol-TUSC2 and erlotinib hydrochloride can help to control NSCLC. The safety of this drug combination will also be studied in both phases. DOTAP:Chol-TUSC2 (previously FUS1) is a drug that helps transfer a gene called TUSC2 into cancer cells. Researchers think that cells without this gene may be involved in the development of lung cancer tumors. They want to find out if replacing the gene in these cells may keep the tissue from forming cancer cells. Erlotinib hydrochloride is designed to block a protein on tumor cells that may control tumor growth and survival. This may stop tumors from growing.
Timeline
- Start
- 2014-02
- Primary completion
- 2016-10-27
- Completion
- 2020-09-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DOTAP:Chol-TUSC2 | Unknown | 0.045 mg/kg | Intravenous |
| Subject | Erlotinib | Small molecule | 100 mg | Oral |
| Background | Dexamethasone | Small molecule | 8 mg | Oral |
| Background | Dexamethasone | Small molecule | 20 mg | Oral |
| Background | Diphenhydramine | Unknown | 50 mg | Oral |