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

Phase 2

Completed

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: Iressa

• Registration Number: NCT00173875
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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)

Detailed Description

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.

Study Timeline

• Study Start: 2005-03
• Status Verified: 2005-07
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Study Completion: 2007-07
• Last Update Submitted: 2007-07-27
• Last Update Posted: 2007-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Iressa	Iressa

Primary Outcome Measures

Name	Time	Method
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	2005~2007

Secondary Outcome Measures

Name	Time	Method
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	2005~2007

Trial Locations

Locations (1)

Department of Oncology, National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan