Status:
COMPLETED
Iressa as a First-Line Treatment in Chemonaive Patients With Inoperable Non-Small Cell Lung Cancer
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00173875
Start Date
March 1 2005
End Date
July 1 2007
Last Update
July 30 2007
Active Locations (1)
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1
Department of Oncology, National Taiwan University Hospital
Taipei, Taiwan