advanced colorectal cancer MedDRA version: 12.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer
Conditions
Interventions
Trade Name: Erbitux
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: CETUXIMAB
CAS Number: 205923564
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentr
Sponsors
VU Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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. - Tumour 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 Tumours (RECIST 1.1). - ECOG Performance Status of 0, 1 or 2 - Adequate liver and renal functions Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the first part of the study is the demonstration of 89Zr-cetuximab uptake in non-hepatic tumour lesions. The main objective of the second part is the association between 89Zr-cetuximab uptake in non-hepatic tumour lesions and treatment outcome.;Secondary Objective: 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 tumour 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 tumour lesions, grade of skin toxicity and response according to RECIST 1.1. ;Primary end point(s): Part one - Primary endpoint The detection of 89Zr-cetuximab uptake in non-hepatic tumour lesions (present/absent; present being defined as levels measured in ROI’s > standard deviation of background +1). Part two – primary endpoint The % uptake (of total injected) 89Zr-cetuximab in non-hepatic tumour lesions as measured in ROI’s corrected for background levels. Part two - secondary endpoints 1) The % uptake (of total injected) 89Zr-cetuximab in liver lesions as measured in ROI’s corrected for background levels. 2) [18F-]FDG PET measurements (SUVmax) before and after 4 weeks of treatment with cetuximab. 3) Grade of skin toxicity as measured by predefined criteria (see below). Other study parameters 4) Serum magnesium levels before and during treatment. 5) EGFR saturation with cetuximab in skin samples. 6) Kinase activity in skin samples before and after treatment | — |
Countries
Netherlands
Outcome results
None listed