metastatic colorectal cancer,
Conditions
Interventions
Patients will be treated with cetuximab. For pharmacodynamic purposes PET-imaging with 89Zr-labelled cetuximab will be performed. In addition, two [18F-]-FDG PET-CT will be performed to explore early
Sponsors
VU Univeristy Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Advanced colorectal adenocarcinoma; 2. Subjects must have been treated according to standard care with a fluoropyrimidine (e.g. fluorouracil or capecitabine), irinotecan, and oxaliplatin or had contra-indications to treatment with these drugs; 3. Age ≥ 18 years; 4. Histological or cytological documentation of cancer is required; 5. Tumor material must be tested wild type for the K-Ras gene; 6. Subjects have at least one measurable lesion outside the liver. Lesions must be evaluated by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1); 7. ECOG Performance Status of 0, 1 or 2; 8. Adequate liver and renal functions as assessed by the following laboratory requirements to be conducted within 7 days prior to screening: A. Total bilirubin ≤ 1.5 times the upper limit of normal; B. ALT and AST ≤ 2.5 times upper limit of normal (≤ 5 times upper limit of normal for subjects with liver involvement of their cancer); C. Serum creatinin ≤ 1.5 times upper limit of normal or a calculated creatinin clearance > 50 ml/min. 9. Signed informed consent must be obtained prior to any study specific procedures.
Exclusion criteria
Exclusion criteria: 1. Previous exposure to an anti-EGFR therapy; 2. Significant skin condition interfering with treatment; 3. Insulin dependency; 4. Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must agree to use adequate barrier birth control measures (e.g., cervical cap, condom, and diaphragm) during the course of the trial. Oral birth control methods alone will not be considered adequate on this study, because of the potential pharmacokinetic interaction between study drug and oral contraceptives. Concomitant use of oral and barrier contraceptives is advised. Contraception is necessary for at least 6 months after receiving study drug; 5. Concurrent anticancer chemotherapy, immunotherapy or investigational drug therapy during the study or within 4 weeks of the start of study drug; 6. Radiotherapy to the target lesions during study or within 4 weeks of the start of study drug. Palliative radiotherapy will be allowed; 7. Major surgery within 28 days of start of study drug; 8. Substance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study results; 9. Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate uptake of 89Zr-cetuximab in non-hepatic tumor lesions using immuno-PET when administered during the loading dose of cetuximab. Part two - Primary objective: To investigate whether there is an association between uptake of cetuximab in non-hepatic tumor lesions and response according to RECIST 1.1 criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To investigate whether there is an association between levels of uptake of 89Zr-cetuximab in the liver compared to levels of uptake in non-hepatic tumor lesions; 2. To explore whether the response observed on [18F]-FDG-PET can serve as an early response marker for future response to targeted therapy according to RECIST 1.1; 3. To explore whether there is an association between 89Zr-cetuximab uptake in non-hepatic tumor lesions, grade of skin toxicity and response according to RECIST 1.1. | — |
Contacts
Public ContactAriëtte Clement
VU University Medical Center De Boelelaan 1117 Room ZKH 3A31
Outcome results
None listed