Non-invasive Imaging of Cetuximab-Zr. 89 Uptake Wit PET: a Phase I Trial in Stage IV Cancer Patients
Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
Participant gender:
Summary
Non invasive imaging of cetuximab uptake with PET could help to select the patients who could
be treated by cetuximab, a registered but expensive monoclonal antibody against EGFR. Other
monoclonal antibodies labelled with Zirconium-89 have already been used with success in
patients. The combination of cetuximab labelled with Zirconium-89 is a promising new probe to
determine cetuximab uptake, which has been tested in various pre-clinical animal models in
Maastricht with excellent results.
We propose a two step study design (see figure 1). As our ultimate goal for the future is to
determine the uptake of 89Zr-cetuximab in the tumour before and during therapy, we need to
investigate the toxicity of two consecutive low doses of 89Zr-cetuximab in the first place.
However, as in future studies and in some patients, it is also possible that a single, larger
dose of 89Zr-cetuximab is needed to obtain the best image quality, we will also investigate
the toxicity of a single larger dose.
Step 1: Determination of the toxicity of two low doses of 89Zr-cetuximab In three patients a
standard loading dose of 400 mg/m2 of cetuximab will be administered, partly labelled with
89Zr (60 MBq, 2.5mg) on day 0.
On day 14, a second injection with dose of 250 mg/m2 of cetuximab, partly labelled with 89Zr
(60 MBq, 2.5mg), will be given.
Step 2: Determination of the toxicity of one larger dose of 89Zr-cetuximab A standard loading
dose of 400 mg/m2 of cetuximab will be administered in 3 patients, a part labelled with 89Zr
(120MBq, 5mg).