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PharmacoEconomic Assessment IRESSA® in the Treatment of Non-Small-Cell Lung Cancer (NSCLC)

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ClinicalTrials.gov Identifier: NCT00173524
Recruitment Status : Unknown
Verified April 2009 by National Taiwan University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 15, 2005
Last Update Posted : May 19, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
The objective of this pharmacoeconomics (PE) study is to evaluate the cost- effectiveness analysis and cost-utility analysis of IRESSA® as first line treatment of NSCLC from the society perspective, based on resources and outcomes from patients who met the inclusion criteria for this naturalistic study comparing to existing first line platinum-based regimen chemotherapy.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Behavioral: PharmacoEconomic Assessment Phase 4

Detailed Description:

Patients with late-stage NSCLC are often symptomatic, with specific pulmonary problems (eg, cough, breathlessness, hemoptysis) and general symptoms (eg. fatigue, weight loss) that can cause extreme distress to the patient. Therefore, improvements in disease-related symptoms and quality of life (QoL) are the key desired outcomes of medical management.7 Effective, palliative, low-toxicity with reasonable treatment cost for patients with advanced NSCLC are needed. Recently, more and more countries consider evidence of economic value along with clinical efficacy.

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. 8,9 Furthermore, high levels of EGFR expression have been associated with a poor prognosis in lung cancer patients in several studies. 10-12 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).13 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 Design

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PharmacoEconomic Assessment IRESSA® in the Treatment of Non-Small-Cell Lung Cancer (NSCLC) : A Cost-Effectiveness Analysis and Cost-Utility Analysis
Study Start Date : September 2005
Estimated Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Behavioral: PharmacoEconomic Assessment
    Collecting PE data.

Outcome Measures

Primary Outcome Measures :
  1. The objective of this PE study is to evaluate the cost- effectiveness analysis and cost-utility analysis of IRESSA® as first line treatment of NSCLC from the society perspective, comparing to existing first line platinum-based regimen chemotherapy. [ Time Frame: 2-3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients accrued to a gefitinib first line prospective study.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00173524


Locations
Taiwan
Department of Oncology, National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Lin Zone-Zhe, M.D. Department of Oncology , National Taiwan University Hospital
Study Chair: Cheng Ann-Lii, M.D.,Ph.D. Department of Oncology , National Taiwan University Hospital
More Information

Responsible Party: Chih-Hsin Yang, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00173524     History of Changes
Other Study ID Numbers: 9461700718
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: May 19, 2009
Last Verified: April 2009

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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms