Image guided treatment optimalization with cetuximab for patients with metastatic colorectal cancer: IMPACT - CRC

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 151

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 is required.
• Tumor material must be tested wild type for the K-RAS and B-RAF gene.
• Tumor lesion:
o Part I: Subjects have at least one measurable lesion = 2 cm outside the liver. Lesions must be evaluable by CT or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
o Part II: Subjects have at least one measurable tumor lesion = 1 cm, including liver tumor lesion. Lesions must be evaluable by CT or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
• 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:
o Total bilirubin = 1.5 times the upper limit of normal
o ALT and AST = 2.5 times upper limit of normal (= 5 times upper limit of normal for subjects with liver involvement of their cancer)
o 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.

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 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 76

Exclusion Criteria

• Previous exposure to an anti-EGFR therapy
• Significant skin condition interfering with treatment
• 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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