Iressa as a First-Line Treatment in Chemonaive Patients With Inoperable Non-Small Cell Lung Cancer

Official Title: “A Phase II Study to Evaluate the Efficacy and Safety of Iressa as a First-Line Treatment in Chemonaive Patients With Inoperable Non-Small Cell Lung Cancer (NSCLC)”

The purpose of this study is to assess the overall response rate to Iressa as a first-line treatment in chemonaive patients with inoperable Non-Small Cell Lung Cancer (NSCLC)

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.Furthermore, high levels of EGFR expression have been associated with a poor prognosis in lung cancer patients in several studies. 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). Iressa is an orally active, selective EGFR tyrosine kinase inhibitor that blocks signal transduction pathways implicated in the proliferation and survival of cancer cells.

Intervention(s) in this Clinical Trial

• Drug: Iressa

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Iressa

Primary Measures

• The primary objective of this study is to assess the overall response rate to Iressa as a first-line treatment in chemonaive patients with inoperable Non-Small Cell Lung Cancer
  • Time Frame: 2005~2007
    

Secondary Measures

• To evaluate 1) Individual response rate 2) Time to progression 3) Overall survival (OS) at year1 4) Progression free survival (PFS) at year1 5) Toxicity
  • Time Frame: 2005~2007
    

Inclusion Criteria:

• Histologically or cytologically confirmed 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:

• 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
• 2nd malignancies
• Unable to swallow tablets
• Patients (M/F) with reproductive potential not implementing adequate contraceptive measurements
• Pregnant or lactating patients
• Participation in other clinical trials within 30 days of study entry
• Major systemic disease which in the investigator's opinion might confound the clinical trial

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: National Taiwan University Hospital Other

Overall Clinical Trial Officials and Contacts

Chin-Hsin Yang, M.D.,Ph.D. Principal Investigator Department of Oncology , National Taiwan University Hospital  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00173875

Study ID Number: 940107

ClinicalTrials.gov Identifier: NCT00173875

Health Authority: Taiwan: Department of Health