Stage IV Cancer Clinical Trial
Official title:
Non Invasive Imaging of Cetuximab-Zirconium-89 Uptake With PET: a Phase I Trial in Stage IV Cancer
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).
Toxicity will be scored twice a week from the day of first injection (day 0) up to day 14,
according to the CTCAE3.0 scoring system. As after 14 days, the activity of Zr89 is low
(four half-lives of Zr89 is 4 x 3.2 days = 12.8 days), no additional toxic effect is
expected. Blood sampling will be done weekly (haematology, liver and kidney function).
When in 0/3 patients a toxicity of grade 3 or more has occurred step 2 is considered safe.
If in 1/3 patients a grade 3 has occurred, 3 more patients will be included in this step. If
another grade 3 toxicity occurs in 1/3 patients, the study will be stopped. When at maximum
1/6 patients experience a grade 3 toxicity, this step will be considered safe. When step 2
is considered safe, the study is ended.
After the injection, visualization of all tumour sites will be analyzed by performing a
PET-CT scan on day 4, 5 and 6 post injection. An additional scan on day 3 or 7 is optional.*
At day 5 post injection a perfusion PET-CT will be performed.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03475589 -
Study on the Adverse Drug Reactions (ADRs) of Apatinib and Their Biomarker Correlations
|
Phase 4 |