To determine the toxicity of Zirconium-89 (Zr89) labelled Cetuximab in patient with stage IV cancer.
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
MTD (Maximum Tolereerbare Dosis) Zirconium-89 labelled Cetuximab in patients
with stage IV cancer
Secondary outcome
Toxicity (CTCAE 3.0)
Optimalisation of tumour visualization
Background summary
Cetuximab has in the past proven to contribute to a better tumour controle. By
visualizing the tumour it can be examined better. Therefore Cetuximab is
labelled to 89-Zirconium.
The safety of this labelled 89-Zirconium-Cetuximab is being examined with this
trial.
Study objective
To determine the toxicity of Zirconium-89 (Zr89) labelled Cetuximab in patient
with stage IV cancer.
Study design
Phase I study with escalating doses Zirconium-89 labelled Cetuximab.
Day 0: Patients receive first dosis of Cetuximab (400 mg/m2) and Zirconium-89
labelled Cetuximab (60 MBq, 10 mg)
Day 4,5 en 6: PET-CT scans
Day 14: patients receive second dosis of Cetuximab (250m g/m2) and Zirconium-89
labelled Cetuximab (120 MBq, 10 mg)
Day 18, 19 en 20: PET-CT scans
Patients included in step 1 and 2 are not selected on basis of EGFR
overexpression. Therefore, if the secondary endpoint, being image quality,
cannot be assessed due to the absence of EGFR overexpression in any of the
primary tumours, a third step will be added in which 3 patients are included
before the start of any treatment, with an EGFR overexpressing tumour on
immunohistochemistry.
Step 3 (3 patients): Determination of the image quality in untreated patients
with tumours overexpressing EGFR
A standard loading dose of 400 mg/m2 of cetuximab will be administered in 3
patients, a part labelled with 89Zr (120MBq, 10mg). After the injection, visualization of all tumour sites will be analyzed by
performing a PET-CT scan on day 4, 5 or 6 post injection, based on the optimal
TBR in step 1 and 2.
Intervention
Eligible patients receive an intravenous dose of Cetuximab and Zirconium-89
labelled Cetuximab twice.
Furthermore blood is drawn twice a week during the study.
Study burden and risks
Patients receive an intravenous dose of Cetuximab and Zirconium-89 labelled
Cetuximab twice. Rarely an allergic reaction can occur from the infusion.
Extra PET-CT scans are made 6 times during the study.
Twice an week blood is drawn during the study.
Dr. Tanslaan 12
6229 ET Maastricht
NL
Dr. Tanslaan 12
6229 ET Maastricht
NL
Listed location countries
Age
Inclusion criteria
- Histological or cytological confirmed stage IV cancer
- Primary or recurrent stage IV (UICC 2002; sixth edition)
- WHO Performance 0-2
- Measurable cancer on PET-scan, i.e. index lesion with a volume of at least 6cm3
- No recent severe cardiac disease
- Adequate bone marrow
- Adequate renal function
- Adequate hepatic function
- Life expectancy > 3 months
- Willing and able to comply with study prescriptions
- 18 years or older
- Not pregant or breast feading
- Written informed consent
- No previous administration of Cetuximab
Exclusion criteria
- Mixed pathology (non-small cell lung cancer plus small cell lung cancer)
- Recent myocardial infarction
- Uncontrolled infectious disease
- Less than 18 years old
- Other active malignancy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-006376-10-NL |
| ClinicalTrials.gov | NCT00691548 |
| CCMO | NL21891.068.08 |