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

July 27, 2007 updated by: National Taiwan University Hospital

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 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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Department of Oncology, National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Iressa
Drug: Iressa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 2005~2007
2005~2007

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 2005~2007
2005~2007

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Chin-Hsin Yang, M.D.,Ph.D., Department of Oncology , National Taiwan University Hospital
  • Study Chair: Ann-Lii Cheng, M.D.,Ph.D., Department of Oncology , National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

July 30, 2007

Last Update Submitted That Met QC Criteria

July 27, 2007

Last Verified

July 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 940107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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