Advanced non-small cell lung cancer (NSCLC)
Conditions
Interventions
Trade Name: Tarceva
Product Name: Tarceva
Product Code: OSI-774
Pharmaceutical Form: Coated tablet
Sponsors
Royal Marsden Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed diagnosis of stage IIIB/IV NSCLC overexpressing EGFR (i.e =10% membrane staining on tumour cells via Dako IHC kit). 2. Patients can receive Tarceva (erlotinib) in first, second or third line settings – situations where Tarceva would be considered appropriate treatment. 3. Must have recovered from any treatment related toxicities regardless of regimen prior to registration, except for alopecia, grade1 fatigue, or grade 1 neurotoxicity 4. Must have measurable disease via CT criteria 5. Age = 18yrs, 6. ECOG 0-2 and predicted life expectancy = 12 weeks 7. Previous surgery: permitted provided that wound healing has occurred prior to registration 8. Adequate haematopoietic, hepatic and renal function defined as follows: · Absolute neutrophil count (ANC) = 1.5 x 109/L and platelet count = 100 x 109/L · Bilirubin within or = 1.5 x ULN, ALT (SGPT) = 2.5 x ULN (or = 5x ULN in cases of liver metastases) · Serum creatinine = 1.5x ULN 9. Accessible for repeat dosing and follow-up. Investigators must assure themselves that the patient registered on this trial will be available for complete documentation of the treatment, toxicity, and follow-up. 10. Patients who have already had a diagnostic PET/CT at the Royal Marsden Hospital in the previous 4 weeks can be considered for entry into the study in they overexpress EGFR as above and Tarceva is considered appropriate treatment for them. They will be assessed after 6 weeks of treatment by a further PET/CT. 11. Patients must provide verbal and written informed consent to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any concurrent anticancer cytostatic or cytotoxic chemotherapy. 2. If the administration of Tarceva to patients receiving concomitant CYP3A4 or CYP1A2 inducers/inhibitors could impact significantly on their clinical care, these patients should be excluded – see appendix 3 3. Any other active malignancies unless deemed cured with at least 5 years of follow-up. In situ cervical cancer and in situ/basal cell skin cancer are permitted. 4. Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with the patient’s ongoing participation in the study. 5. History of psychiatric condition that might impair the patients ability to understand or to comply with the requirements of the study or to provide informed consent 6. Gastro-intestinal abnormalities, including inability to take oral medication, requirement for iv alimentation, active peptic ulcer or prior surgical procedures affecting absorption 7. Inability to lie flat for the duration of the PET scan (for up to 2 hours).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether using PET/CT scans at baseline and at 6 weeks will be more predictive of response to Tarceva than standard scanning methods in patients with NSCLC.;Secondary Objective: To correlate radiological response with symptomatic response, duration of treatment and survival.; Primary end point(s): 1. Document early response or progression in patients after 6 weeks of erlotinib by PET/CT scanning. 2. Compare PET/CT findings at 6 weeks to standard CT scan at 12 weeks. 3. Document symptomatic response at 6 & 12 weeks and compare to radiological findings. | — |
Countries
United Kingdom
Outcome results
None listed