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

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Gefitinib

Criteria

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