Overview

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