Back to resultsIressa as a First-Line Treatment in Chemonaive Patients With Inoperable Non-Small Cell Lung Cancer
Primary Purpose
Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Iressa
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring EGFR Non-small cell lung cancer
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
Sites / Locations
- Department of Oncology, National Taiwan University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Iressa
Outcomes
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
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
Full Information
NCT ID
NCT00173875
First Posted
September 8, 2005
Last Updated
July 27, 2007
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00173875
Brief Title
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
2. Study Status
Record Verification Date
July 2005
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
EGFR Non-small cell lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Iressa
Intervention Type
Drug
Intervention Name(s)
Iressa
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chin-Hsin Yang, M.D.,Ph.D.
Organizational Affiliation
Department of Oncology , National Taiwan University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ann-Lii Cheng, M.D.,Ph.D.
Organizational Affiliation
Department of Oncology , National Taiwan University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Oncology, National Taiwan University Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Iressa as a First-Line Treatment in Chemonaive Patients With Inoperable Non-Small Cell Lung Cancer
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