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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00234468
Other study ID # 1839IL/0126
Secondary ID
Status Terminated
Phase Phase 3
First received October 5, 2005
Last updated May 19, 2011
Start date January 2004
Est. completion date August 2007

Study information

Verified date May 2011
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 if to determine if Iressa can prolong the period of time without any disease worsening (Time to progression) in patients previously treated with combined therapy such as surgery and chemotherapy with or without radiotherapy or chemotherapy and radiotherapy


Recruitment information / eligibility

Status Terminated
Enrollment 490
Est. completion date August 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Histologically Confirmed Non Small Cell Lung Cancer.

- Locally advanced disease previously treated with combined therapy (chemotherapy and surgery with or without radiotherapy, or chemotherapy and radiotherapy).

- Chemotherapy with regimens containing cisplatin or carboplatin is mandatory

- Response to combined therapy

Exclusion Criteria:

- No previous treatment with ZD1839 or any other EGFR-targeted therapy

- No progressive disease after combined therapy for locally advanced NSCLC

- No presence of metastatic disease

- 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 unresolved chronic toxicity from previous anticancer therapy.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Drug:
Iressa (Gefitinib)


Locations

Country Name City State
Italy Research Site Avellino
Italy Research Site Bergamo
Italy Research Site Bologna
Italy Research Site Cagliari
Italy Research Site Campobasso
Italy Research Site Catania
Italy Research Site Catanzaro
Italy Research Site Chieti
Italy Research Site Cosenza
Italy Research Site Della Fratte
Italy Research Site Emilia
Italy Research Site Fano
Italy Research Site Firenze
Italy Research Site Forli
Italy Research Site Frattamaggiore
Italy Research Site Livorno
Italy Research Site Messina
Italy Research Site Milano
Italy Research Site Napoli
Italy Research Site Novara
Italy Research Site Orbassano
Italy Research Site Padova
Italy Research Site Palermo
Italy Research Site Pavia
Italy Research Site Potenza
Italy Research Site Ravenna
Italy Research Site Rimini
Italy Research Site Roma
Italy Research Site San Giovanni Rotondo
Italy Research Site Sassari
Italy Research Site Taormina
Italy Research Site Venezia-Mestre

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to progression (2 years after Last patient in)
Secondary Modalities of relapse or progression (2 years after Last patient in)
Secondary Overall survival (2 years after Last patient in)
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