Image Guided Treatment Optimization With Cetuximab for Patients With Metastatic Colorectal Cancer

• Status: Terminated
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

Summary

In this study the investigators will evaluate the uptake of 89Zirconium labeled cetuximab in extra-hepatic colorectal metastases. The investigators hypothesize that uptake of 89Zr-cetuximab is required for response to cetuximab. If no uptake is present the investigators will escalate the dose cetuximab and repeat the 89Zr-cetuximab PET.

The investigators will evaluate the clinical benefit rate of cetuximab in the patients with and without uptake. The ultimate goal is to create a selection tool that can predict response of cetuximab.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VU University Medical Center
• Collaborators: Radboud University; University Medical Center Groningen
• Treatments: Cetuximab

Criteria

Inclusion Criteria:

Subjects are eligible if they meet the following criteria:

• Advanced colorectal adenocarcinoma

• Subjects must have been treated according to standard care with palliative chemotherapy including a fluoropyrimidine (e.g. fluorouracil or capecitabine), irinotecan, and oxaliplatin or had contra-indications to treatment with these drugs.

• No local treatment options

• Life expectancy of at least 12 weeks.

• Age => 18 years.

• Histological or cytological documentation of cancer is required.

• Tumor material must be tested wild type for the K-RAS (codon 12, 13, 61, 117, 146) and N-RAS (codon 12, 13, 61, 117, 146) genes.

• 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).

• ECOG (Eastern Cooperative Oncology Group) 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 start of treatment:

• Total bilirubin ≤ 1.5 times the upper limit of normal

• ALT (alanine aminotransferase) and AST (aspartate aminotransferase) ≤ 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.

Exclusion Criteria:

Subjects who meet the following criteria at the time of screening will be excluded:

• 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.