Treatment Optimization of Cetuximab in Patients With Metastatic Colorectal Cancer Based on Tumor Uptake of 89Zr-labeled Cetuximab Assessed by PET
- Advanced colorectal adenocarcinoma
- 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.
- Age ≥18 years.
- Histological or cytological documentation of cancer is required.
- Tumor material must be tested wild type for the K-Ras gene.
- 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
- ECOG Performance Status of 0, 1 or 2
- Adequate liver and renal functions as assessed by the following laboratory
requirements to be conducted within 7 days prior to screening:
- Total bilirubin ≤ 1.5 times the upper limit of normal
- ALT and AST ≤ 2.5 times upper limit of normal (≤ 5 times upper limit of normal
for subjects with liver involvement of their cancer)
- Serum creatinin ≤ 1.5 times upper limit of normal or a calculated creatinin
clearance ≥ 50 ml/min
- Signed informed consent must be obtained prior to any study specific procedures.
- Previous exposure to an anti-EGFR therapy
- Significant skin condition interfering with treatment
- Insulin dependency
- 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.
- Concurrent anticancer chemotherapy, immunotherapy or investigational drug therapy
during the study or within 4 weeks of the start of study drug.
- Radiotherapy to the target lesions during study or within 4 weeks of the start of
study drug. Palliative radiotherapy will be allowed.
- Major surgery within 28 days of start of study drug.
- Substance abuse, medical, psychological or social conditions that may interfere with
the subject's participation in the study or evaluation of the study results.
- Any condition that is unstable or could jeopardize the safety of the subject and
their compliance in the study.