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

NHS Foundation Trust

Status and phase

Terminated

Phase 2

Conditions

Lung Cancer

Head and Neck Cancer

Treatments

Drug: Gefitinib

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01405846

11/H0304/8 (Other Identifier)

2010-023355-29 (EudraCT Number)

P01425

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.