THE USE OF PET/CT SCANNING TO ASSESS EARLY RESPONDERS TO TARCEVA (ERLOTINIB): A PHASE II STUDY - PET/CT scanning to assess response to Tarceva

Royal Marsden Hospital0 sites47 target enrollmentOctober 14, 2005

Overview

No summary available.

Registry

who.int

Start Date

October 14, 2005

End Date

March 31, 2008

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Royal Marsden Hospital

•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)

•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).