Feasibility Study to Estimate Number of Patients With Precancerous Areas in Their Airways and the Response to Gefitinib (TIDAL1)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Papworth Hospital NHS Foundation Trust
Sponsor:
Collaborators:
AstraZeneca
Noble Organisation
Information provided by (Responsible Party):
Papworth Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01405846
First received: July 28, 2011
Last updated: December 30, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Head and Neck Cancer
Drug: Gefitinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tyrosine Kinase Inhibitors in DyplAsia of Lung Epithelium

Resource links provided by NLM:


Further study details as provided by Papworth Hospital NHS Foundation Trust:

Primary Outcome Measures:
  • Incidence of high grade dysplasia of the bronchial epithelium in patients at high risk of lung dysplasia [ Time Frame: during the screening broncoscopy - carried out within the first month post consent ] [ Designated as safety issue: No ]
    Patients will have white/blue light bronchoscopy with biopsy of identified lesions. The incidence of high grade lung epithelial dysplasia will be recorded.


Secondary Outcome Measures:
  • Acceptability of screening patients as measured by success of trial recruitment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Response of high grade dysplasia to treatment (complete / partial / stable / progression) [ Time Frame: 6 & 12 months ] [ Designated as safety issue: No ]

    To be estimated by photography & biopsy of the lesions & comparison with previous findings:

    Complete response: Complete resolution of a dysplastic lesion Partial response: Reduction of a dysplastic lesion by >=50% OR Reduction in grade of a high grade dysplastic lesion Progressive disease: Development of a new area of high grade dysplasia or invasive malignancy in an area of previous low grade dysplasia or normal epithelium OR Development of a higher grade lesion in an area of previous high grade dysplasia OR Increase in surface area of >=50%.

    Stable disease: None of the above.


  • Toxicity and acceptability of treatment (proportion of patients refusing study entry). [ Time Frame: 2 weeks, 4 weeks, 3 & 6 months ] [ Designated as safety issue: Yes ]
  • Successful biobanking of samples [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Gefitinib
Single arm study
Drug: Gefitinib
250mg od for 6 months
Other Name: IRESSA

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Age 18 years or above
  • Resected NSCLC or Squamous cell Head & Neck cancer treated curatively
  • All treatment, including any adjuvant treatment with radiotherapy and/or chemotherapy completed at least 3 months prior to study entry
  • ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1
  • Suitable for flexible bronchoscopy
  • Able to give signed informed consent
  • Adequate haematological, kidney and liver function:

    • Serum alanine transaminase (ALT) ≤2.5 x upper limit of normal (ULN)
    • Total serum bilirubin ≤1.5 x ULN
    • Absolute neutrophil count (ANC) ≥1500/μL
    • Platelets ≥100,000/μL
    • Haemoglobin ≥9.0 g/dL
    • Sufficient renal function to allow administration of contrast medium (in line with Royal College of Radiologists guidelines).

In addition, the following inclusion criteria must be met during the screening period in order to confirm eligibility for the study treatment

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405846

Contacts
Contact: Vikki Hughes, PhD 01480 364821 victoria.hughes@papworth.nhs.uk
Contact: Amanda Stone 01480 364203 amanda.stone@papworth.nhs.uk

Locations
United Kingdom
Papworth Hospital NHS Trust Recruiting
Papworth Everard, Cambs, United Kingdom, CB23 3RE
Principal Investigator: Robert Rintoul, Dr         
Sponsors and Collaborators
Papworth Hospital NHS Foundation Trust
AstraZeneca
Noble Organisation
Investigators
Study Chair: Tim Eisen, Professor Papworth Hospital NHS Trust
Principal Investigator: Robert Rintoul, Dr Papworth Hospital NHS Trust
  More Information

No publications provided

Responsible Party: Papworth Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01405846     History of Changes
Other Study ID Numbers: P01425, 2010-023355-29, 11/H0304/8
Study First Received: July 28, 2011
Last Updated: December 30, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Head and Neck Neoplasms
Lung Neoplasms
Neoplasms by Site
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
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 July 29, 2014