Non-Small Cell Lung Cancer Clinical Trial
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)
Verified date | July 2005 |
Source | National Taiwan University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Department of Health |
Study type | Interventional |
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)
Status | Completed |
Enrollment | 108 |
Est. completion date | July 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | Department of Oncology, National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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