Iressa vs Placebo as Maintenance Therapy in Locally Advanced NSCLC
This study has been terminated.
(Closed due to insufficient recruitment)
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00234468
First received: October 5, 2005
Last updated: May 19, 2011
Last verified: May 2011
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Non Small Cell Lung Carcinoma |
Drug: Iressa (Gefitinib) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Phase III, Double-Blind, Randomised Study Comparing ZD1839 (IressaTM) Versus Placebo As Maintenance Therapy In Subjects With Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC) After Combined Modality Therapy |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Time to progression (2 years after Last patient in)
Secondary Outcome Measures:
- Modalities of relapse or progression (2 years after Last patient in)
- Overall survival (2 years after Last patient in)
| Estimated Enrollment: | 490 |
| Study Start Date: | January 2004 |
| Study Completion Date: | August 2007 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00234468
Locations
| Italy | |
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| Avellino, Italy | |
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| Bergamo, Italy | |
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| Bologna, Italy | |
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| Cagliari, Italy | |
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| Campobasso, Italy | |
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| Catania, Italy | |
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| Catanzaro, Italy | |
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| Chieti, Italy | |
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| Cosenza, Italy | |
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| Della Fratte, Italy | |
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| Emilia, Italy | |
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| Fano, Italy | |
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| Firenze, Italy | |
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| Forli, Italy | |
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| Frattamaggiore, Italy | |
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| Livorno, Italy | |
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| Messina, Italy | |
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| Milano, Italy | |
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| Napoli, Italy | |
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| Novara, Italy | |
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| Orbassano, Italy | |
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| Padova, Italy | |
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| Palermo, Italy | |
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| Pavia, Italy | |
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| Potenza, Italy | |
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| Ravenna, Italy | |
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| Rimini, Italy | |
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| Roma, Italy | |
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| San Giovanni Rotondo, Italy | |
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| Sassari, Italy | |
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| Taormina, Italy | |
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| Venezia-Mestre, Italy | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Principal Investigator: | Lucio Crino, MD | Bologna Italy |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00234468 History of Changes |
| Other Study ID Numbers: | 1839IL/0126 |
| Study First Received: | October 5, 2005 |
| Last Updated: | May 19, 2011 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by AstraZeneca:
|
Locally Advanced Non Small Cell Lung Cancer (Stage IIIA and IIIB) |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms |
Neoplasms by Site 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 May 19, 2013