Feasibility Study to Estimate Number of Patients With Precancerous Areas in Their Airways and the Response to Gefitinib

NCT ID: NCT01405846

Last Updated: 2016-08-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2016-06-30

Brief Summary

We are going to use a special type of bronchoscopy test to examine patients who have had previous surgical treatment for lung cancer or head and neck cancer. The aim is to determine a) whether we can identify precancerous changes in their airways b) whether this type of testing is acceptable and c) get an initial idea of whether a new drug called gefitinib has any effect on precancerous areas in the airway.

Conditions

Lung Cancer; Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gefitinib

Single arm study

Group Type: OTHER

Gefitinib

Intervention Type: DRUG

250mg od for 6 months

Interventions

Gefitinib

250mg od for 6 months

Intervention Type: DRUG

Other Intervention Names

IRESSA

Eligibility Criteria

Inclusion Criteria

• No evidence of malignant disease activity on screening
• High grade dysplasia on autofluorescence bronchoscopy analysis
• No evidence of pulmonary fibrosis or interstitial lung disease on screening CT

Exclusion Criteria

• Diagnosis of any second malignancy within the 5 years from date of enrolment, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that has been adequately treated with no evidence of recurrent disease for 12 months
• Evidence of severe or uncontrolled systemic disease or psychiatric disorder that would interfere with the patient's safety
• Known severe hypersensitivity to Gefitinib or any of the excipients of the product
• Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease
• Pre-existing idiopathic pulmonary fibrosis
• History of allergy to contrast medium
• Insufficient lung function as determined by either clinical examination or an arterial oxygen tension (PaO2) of < 9.3kpa
• Inability to swallow oral medications
• Presence of active inflammatory bowel disease, partial or complete bowel obstruction or chronic diarrhoea or any condition which would interfere with absorption of an oral drug.
• Past medical history of keratitis
• Past medical history of Sjogren's syndrome
• Pregnant or breast-feeding
• Male and female patients (of childbearing age) not using, or not willing to use, protocol mandated contraception
• Prior EGFR inhibitor use.
• Concurrent medication with known potent CYP3A4 inhibitors and inducers and/or dosing within 7 days of date of enrolment (e.g.. ketoconazole, rifampin, phenytoin, carbamazepine, barbiturates or herbal preparations containing St John's wort/Hypericum perforatum etc.) or use of other concomitant medication incompatible with study drug (see SmPC)
• Current treatment on another therapeutic clinical trial or previous investigational agent in the last 12 weeks (supportive care trials or non-treatment trials are allowed)
• Previous enrolment or treatment in the present study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Noble Organisation

UNKNOWN

Sponsor Role: collaborator

Papworth Hospital NHS Foundation Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tim Eisen, Professor

Role: STUDY_CHAIR

Papworth Hospital NHS Trust

Robert Rintoul, Dr

Role: PRINCIPAL_INVESTIGATOR

Papworth Hospital NHS Trust

Locations

Papworth Hospital NHS Trust

Papworth Everard, Cambs, United Kingdom

Countries

United Kingdom

Other Identifiers

2010-023355-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

11/H0304/8

Identifier Type: OTHER

Identifier Source: secondary_id

P01425

Identifier Type: -

Identifier Source: org_study_id