Trial information
A Pilot Study of FDG- and FLT PET in Patients With Non-Small Cell Lung Cancer Treated with Tarceva (Erlotinib).
Status: Recruiting
Protocol number: ML20773
Sponsor: Hoffmann-La Roche; Genentech Inc.
Company division: Pharmaceutical
Official Scientific Title: AN OPEN-LABEL,PILOT STUDY OF CHANGES IN FDG- AND FLT PET IMAGING IN PATIENTS WITH NON-SMALL CELL LUNG CANCER FOLLOWING TREATMENT WITH TARCEVA
Brief summary: This study will evaluate changes occuring in FDG- and FLT-PET imaging as a result of treatment with Tarceva in patients with recurrent or refractory non-small cell lung cancer, in order to assess whether these imaging technologies may be used as surrogate efficacy markers. Patients will undergo PET and CT scans at screening; eligible patients will then receive Tarceva (150mg po daily). They will undergo FDG- and FLT-PET scans on day 14, and PET and CT scans on day 56. Additional CT scans will be conducted every 56 days on study. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.In the US this trial is sponsored/managed by Genentech. Target sample size is
30.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Non-Small Cell Lung Cancer
Intervention type: Drug
Intervention name: erlotinib[Tarceva]
Primary outcome: 1. FDG- and FLT-PET responses (decrease of >25% in mSUVmax at 14 days)
Key secondary outcomes: 1. FDG and FLT-PET responses (decrease of >25% in mSUVmax at 56 days). Safety: AEs, laboratory parameters.
Inclusion criteria:
- adult patients, >= 18 years of age;
- non-small cell lung cancer;
- recurrent or progressive disease after 1-2 chemotherapy regimens for advanced or metastatic non-small cell lung cancer;
- at least one detectable lesion on FDG-PET and/or FLT-PET scan measurable on CT;
- ECOG 0-2.
Exclusion criteria:
- prior treatment with an EGFR inhibitor;
- chemotherapy, radiotherapy or investigational treatment within 14 days or within 5 half-lives of the active molecules in the treatment;
- history of other malignancy in past 2 years, unless it has been adequately treated.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: December, 2006
Trial registration date: 03/19/2007
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Australia
- Brisbane
- Chermside
- Heidelberg
- Melbourne
