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Sponsored by: |
National Cancer Center, Korea |
Information provided by: | National Cancer Center, Korea |
ClinicalTrials.gov Identifier: | NCT00452244 |
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, we 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.
Condition | Intervention | Phase |
Lung Cancer |
Drug: Gefitinib+simvastatin Drug: gefitinib only |
Phase II |
MedlinePlus related topics: | Cancer Lung Cancer |
ChemIDplus related topics: | ZD1839 Simvastatin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Phase II Trail Comparing Gefitinib Plus Simvastatin and Gefitinib Alone in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC) |
Estimated Enrollment: | 94 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Iressa + simvastatin
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Drug: Gefitinib+simvastatin
Gefitinib 250mg/QD po daily every 3 weeks plus Simvastatin 40mg/QD po daily every 3 weeks
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2: Active Comparator
Iressa only
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Drug: gefitinib only
gefitinib 250mg/QD po daily every 3 weeks
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Randomization
Gefitinib (250 mg per day) + Simvastatin (40 mg per day) PO or Gefitinib (250 mg per day) alone
until progression or unacceptable toxicity
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ji-Youn Han, M.D.,Ph.D. | +82-31-920-1154 | jymama@ncc.re.kr |
Korea, Republic of, Gyeonggi-do | |||||
National Cancer Center, Korea | Recruiting | ||||
Goyang-si, Gyeonggi-do, Korea, Republic of | |||||
Sub-Investigator: Jin Soo Lee, M.D. | |||||
Sub-Investigator: Heung Tae Kim, M.D. | |||||
Sub-Investigator: Soo-Hyun Lee, M.D. | |||||
Principal Investigator: Ji-Youn Han, M.D. | |||||
Sub-Investigator: Tak Yun, M.D. |
National Cancer Center, Korea |
Principal Investigator: | Ji-Youn Han, M.D.,Ph.D. | National Cancer Center, Korea |
Responsible Party: | National Cancer Center, Korea ( Ji-Youn Han ) |
Study ID Numbers: | NCCCTS-06-177 |
First Received: | March 26, 2007 |
Last Updated: | January 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00452244 |
Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
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