NCT00452244

Gefitinib With or Without Simvastatin in Non-Small Cell Lung Cancer (NSCLC)

Randomized Phase II Trail Comparing Gefitinib Plus Simvastatin and Gefitinib Alone in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The epidermal growth factor receptor (EGFR) is a key regulator of growth, differentiation, and survival of epithelial cancers. In a small subset of tumors, the presence of activating mutations within the ATP binding site confers increased susceptibility to gefitinib, a potent tyrosine kinase inhibitor of EGFR. Agents that can inhibit EGFR function through different mechanisms may enhance gefitinib activity in patients lacking these mutations. Mevalonate metabolites play significant roles in the function of the EGFR; therefore, mevalonate pathway inhibitors may potentiate EGFR-targeted therapies. Targeting HMG-CoA reductase, the rate-limiting enzyme of mevalonate pathway, using lovastatin induces a potent apoptosis in a variety of tumor types. In an in vitro study, combining gefitinib and lovastatin treatment showed synergistic cytotoxic activity through enhanced inhibition of AKT activation by EGF in NSCLC and head \& neck cancer cell lines. Therefore, the investigators would like to compare the combination effect of gefitinib and simvastatin, the specific and protein inhibitor of HMG-CoA reductase, with gefitinib alone in previously treated patients with NSCLC.

Detailed description

Randomization 1. Sex (female vs. male) 2. ECOG PS (0/1 vs. 2/3) 3. Number of prior regimen (one vs. two). Gefitinib (250 mg per day) + Simvastatin (40 mg per day) PO or Gefitinib (250 mg per day) alone until progression or unacceptable toxicity

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	simvastatin	Simvastatin 40mg/QD po daily every 3 weeks
DRUG	gefitinib only	gefitinib 250mg/QD po daily every 3 weeks

Timeline

• Start date: 2006-05-01
• Primary completion: 2011-02-01
• Completion: 2011-03-01
• First posted: 2007-03-27
• Last updated: 2017-08-25

Locations

1 site across 1 country: South Korea