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

NCT01405846 | Terminated Phase 2 DMC

• 3 other identifiers: P014252010-023355-2911/H0304/8
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of high grade dysplasia of the bronchial epithelium in patients at high risk of lung dysplasia

  Patients will have white/blue light bronchoscopy with biopsy of identified lesions. The incidence of high grade lung epithelial dysplasia will be recorded.

  during the screening broncoscopy - carried out within the first month post consent

Secondary Outcomes (4)

• Acceptability of screening patients as measured by success of trial recruitment

  12 months

• Response of high grade dysplasia to treatment (complete / partial / stable / progression)

  6 & 12 months

• Toxicity and acceptability of treatment (proportion of patients refusing study entry).

  2 weeks, 4 weeks, 3 & 6 months

• Successful biobanking of samples

  12 months

Study Arms (1)

Gefitinib

OTHER

Single arm study

Drug: Gefitinib

Interventions

Gefitinib DRUG

250mg od for 6 months

Also known as: IRESSA

Gefitinib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead
• AstraZeneca: collaborator
• Noble Organisation: collaborator

Study Sites (1)

Papworth Hospital NHS Trust

Papworth Everard, Cambs, CB23 3RE, United Kingdom

Location

MeSH Terms

Conditions

Lung Neoplasms; Head and Neck Neoplasms

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Tim Eisen, Professor

  Papworth Hospital NHS Trust

  STUDY CHAIR

• Robert Rintoul, Dr

  Papworth Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2011
• First Posted: July 29, 2011
• Study Start: December 1, 2011
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 19, 2016

Record last verified: 2016-08

Locations

GB (1)