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Iressa as a First-Line Treatment in Chemonaive Patients With Inoperable Non-Small Cell Lung Cancer

NCT ID: NCT00173875

Last Updated: 2007-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2007-07-31

Brief Summary

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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

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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.

Conditions

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Non-Small Cell Lung Cancer

Keywords

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EGFR Non-small cell lung cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Iressa

Group Type EXPERIMENTAL

Iressa

Intervention Type DRUG

Interventions

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Iressa

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Chin-Hsin Yang, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Oncology , National Taiwan University Hospital

Ann-Lii Cheng, M.D.,Ph.D.

Role: STUDY_CHAIR

Department of Oncology , National Taiwan University Hospital

Locations

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Department of Oncology, National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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940107

Identifier Type: -

Identifier Source: org_study_id