FUS1-nanoparticles and Erlotinib in Stage IV Lung Cancer
The goal of phase 1 of this clinical research study is to find the highest dose of DOTAP:Chol-fus1 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-fus1 and erlotinib hydrochloride can help to control NSCLC.
The safety of this drug combination will also be studied in both phases.
DOTAP:Chol-fus1 is a drug that helps transfer a gene called fus1 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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Clinical Trial Combining FUS1-nanoparticles and Erlotinib in Stage IV Lung Cancer|
- Maximum Tolerated Dose (MTD) Level for Drug Treatment Combination [ Time Frame: First 21 day cycle ] [ Designated as safety issue: No ]MTD defined as dose level at which less than 2 participants experience dose-limiting toxicity (DLT). Toxicity graded according to National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 4. DLT will be grade > 3 toxicity occurring during the first cycle of therapy (i.e., within the first 3 weeks).
- Response Rate [ Time Frame: After two, 21 day cycles ] [ Designated as safety issue: No ]Responses determined by RECIST criteria. Responses will include only complete response (CR) + partial response (PR). Participants considered as non-responders when tumor progression by RECIST is observed. Measurable disease is defined as tumor masses with identifiable diameters measurable in two dimensions by computed tomography. Best overall response is best response designation recorded from the start of treatment until disease progression. Complete and partial responses have to be confirmed by two evaluations of the disease taken at least four weeks apart.
|Study Start Date:||February 2014|
|Estimated Primary Completion Date:||March 2018 (Final data collection date for primary outcome measure)|
Experimental: DOTAP + Erlotinib
DOTAP:Chol-fus1 0.045 mg/kg by vein over 25-35 minutes on day 1 of each 21 day cycle; and Erlotinib 100 mg by mouth daily for each 21 day cycle.
Starting Dose 0.045 mg/kg by vein on day 1 of each 21 day cycle; Phase II is Maximum Tolerated Dose from Phase I.
Other Name: DOTAP:Cholesterol-Fus1 Liposome ComplexDrug: Erlotinib
Starting Dose 100 mg by mouth each day of a 21 day cycle (except for first week of Cycle 1, if enrolled in Phase II delayed-schedule group). Phase II is Maximum Tolerated Dose from Phase I.
Other Names:Drug: Dexamethasone
8 mg orally 24 and 12 hours and 20 mg by vein 30 minutes before DOTAP:Chol-fus1 treatment followed by 8 mg orally at 12, 24 and 36 hours after treatment (total number doses = 5).
Other Name: DecadronDrug: Diphenhydramine
50 mg by mouth or by vein 30 minutes prior to treatment with DOTAP:Chol FUS1
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01455389
|Contact: Charles Lu, MD||713-792-6363|
|United States, Texas|
|UT MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Charles Lu, MD||UT MD Anderson Cancer Center|