Clinical trial NCT00173875: Iressa as a First-Line Treatment in Chemonaive Patients With Inoperable Non-Small Cell Lung Cancer
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: EGFR Non-small cell lung cancer
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 108
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
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
timeFrame: 2005~2007
Secondary outcomes:
measure: 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
timeFrame: 2005~2007
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Oncology, National Taiwan University Hospital
Study officials:
affiliation: Department of Oncology , National Taiwan University Hospital
name: Chin-Hsin Yang, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Oncology , National Taiwan University Hospital
name: Ann-Lii Cheng, M.D.,Ph.D.
role: STUDY_CHAIR
References: