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)
20 Years
N/A
Both
Non-Small Cell Lung Cancer
Trial Information
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)
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Outcome Time Frame:
2005~2007
Principal Investigator
Chin-Hsin Yang, M.D.,Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Oncology , National Taiwan University Hospital
Authority:
Taiwan: Department of Health
Study ID:
940107
NCT ID:
NCT00173875
Start Date:
March 2005
Completion Date:
July 2007
Related Keywords:
- Non-Small Cell Lung Cancer
- EGFR Non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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