Iressa in the Treatment of Brain Metastases From Non Small Cell Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

Official title:

A Phase II, Multicentre, Non-Comparative, Open-Label Study To Evaluate The Efficacy And Tolerability Of ZD1839 (Iressa™) In Asymptomatic Radio-Naive Patients With Brain Metastases From Non-Small Cell Lung Carcinoma (NSCLC) Who Have Relapsed Following Prior Chemotherapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00234442
• Other study ID #: 1839IL/0569
• Status: Terminated
• Phase: Phase 2
• First received: October 5, 2005
• Last updated: June 29, 2009
• Start date: July 2004
• Est. completion date: February 2006

Study information

• Verified date: June 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to determine if Iressa is effective in the treatment of Brain metastases from NCSLC

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Radiologically confirmed brain metastases from Non Small Cell Lung Cancer

• No symptoms due to brain metastases

• No previous radiotherapy treatment for the Brain metastases

Exclusion Criteria:

• No prior chemotherapy

• No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ

• Any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Intervention

Drug:
• Iressa (Gefitinib)

Locations

Country	Name	City	State
Italy	Research Site	Bologna
Italy	Research Site	Orbassano
Italy	Research Site	Parma
Italy	Research Site	Rozzano

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease control rate (complete response, partial response and stable disease)
Secondary	Duration of response
Secondary	Time to progression
Secondary	Overall Survival