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

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00173875
First received: September 8, 2005
Last updated: July 27, 2007
Last verified: July 2005
  Purpose

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)


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: Iressa
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 108
Study Start Date: March 2005
Study Completion Date: July 2007
Arms Assigned Interventions
Experimental: A
Iressa
Drug: Iressa

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00173875

Locations
Taiwan
Department of Oncology, National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00173875     History of Changes
Other Study ID Numbers: 940107
Study First Received: September 8, 2005
Last Updated: July 27, 2007
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
EGFR Non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014