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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase IV Natural history/Epidemiology, Treatment Active 20 and over Other 9461700718 NCT00173524

Trial Description

Summary

The objective of this pharmacoeconomics (PE) study is to evaluate the cost- effectiveness analysis and cost-utility analysis of IRESSA® as first line treatment of NSCLC from the society perspective, based on resources and outcomes from patients who met the inclusion criteria for this naturalistic study comparing to existing first line platinum-based regimen chemotherapy.

Further Study Information

Patients with late-stage NSCLC are often symptomatic, with specific pulmonary problems (eg, cough, breathlessness, hemotypsis) and general symptoms (eg, fatigue, weight loss) that can cause extreme distress to the patient. Therefore, improvements in disease-related symptoms and quality of life (QoL) are the key desired outcomes of medical management.7 Effective, palliative, low-toxicity with reasonable treatment cost for patients with advanced NSCLC are needed. Recently, more and more countries consider evidence of economic value along with clinical efficacy.

The epidermal growth factor receptor (EGFR) is a promising target for anticancer therapy because it is expressed or highly expressed in a variety of tumors, including NSCLC. 8,9 Furthermore, high levels of EGFR expression have been associated with a poor prognosis in lung cancer patients in several studies. 10-12 EGFR-targeted cancer therapies are currently being developed; strategies include inhibition of the intracellular tyrosine kinase domain of the receptor by small molecules such as gefitinib (Iressa [ZD1839]; AstraZeneca, Wilmington, DE).13 Iressa is an orally active, selective EGFR tyrosine kinase inhibitor that blocks signal transduction pathways implicated in the proliferation and survival of cancer cells.

Eligibility Criteria

Inclusion Criteria:

• Histologically or cytologicallyconfirmed stage IIIB/IV NSCLC No immediate need for palliative radiotherapy and No prior chemotherapy ; age > 20 Y/O; ECOG PS: 0 – 2; ANC >2000 ; PLT >100k ; Hb > 10; total bilirubin < 2.0 mg/dL; serum creatinine < 2 mg/dl; SGPT and SGOT < 2.5 ×ULN, alkaline phosphatase < 5 ×ULN ; life expectancy >6mos

Exclusion Criteria:

• 1) If the patients have brain metastases or receive radiotherapy, the disease must be stable for more than 6 weeks after the last dose of radiotherapy;2) 2nd malignancies;3) Unable to swallow tablets;4) Patients (M/F) with reproductive potential not implementing adequate contraceptive measurements;5) Pregnant or lactating patients;6) Participation in other clinical trials within 30 days of study entry;7) Major systemic disease which in the investigator’s opinion might confound the clinical trial.

Trial Contact Information

Trial Lead Organizations/Sponsors

National Taiwan University Hospital

Lin Zone-Zhe, M.D.

Principal Investigator

Cheng Ann-Lii, M.D.,Ph.D.

Study Chair

Yang Chin-Hsin, M.D.,Ph.D.		Ph: 886-2-23123456 Ext.7511
		Email: chjyang@ha.mc.ntu.edu.tw

Taiwan, Province of China
	Taipei
	National Taiwan University Hospital
		Yang Chih-Hsin, M.D.,Ph.D.	Ph: 886-2-23123456 Ext.7511
			Email: chjyang@ha.mc.ntu.edu.tw

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00173524
Information obtained from ClinicalTrials.gov on May 27, 2008