Cetuximab Therapy for Third Line Rechallenge in Metastatic Colorectal Cancer

NCT ID: NCT03524820

Last Updated: 2022-08-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-17
• Study Completion Date: 2021-12-31

Brief Summary

This research is intended to check the benefit of treatment with cetuximab in metastatic colorectal cancer patients with wild type RAS as third line treatment. The advantage to the patients is unclear. This study will look if mutations in patients' blood area predictive marker for progression free time (FPT) in metastatic colorectal cancer patients treated with third line cetuximab. A predictive marker for FPT metastatic colorectal cancer patients treated with third line cetuximab will enable a reduction in the number of treated patients. Treatment only of patients with a positive marker is expected to prevent inefficient treatment which will reduce suffering for the patients and reduce unnecessary medical treatment.

Detailed Description

This research is intended to check the benefit of treatment with cetuximab in metastatic colorectal cancer patients with wild type RAS as third line treatment, following first line cetuximab treatment and other second line treatments. The hypothesis is that most cetuximab sensitive cells will be eliminated in the first line of treatment, but may reemerge following other second line treatments which are targeted to other clones in the tumor. The advantage to the patients is unclear, however some preliminary studies show advantage to patients. This study will look if mutations in patients' blood are a predictive marker for progression free time (FPT) in metastatic colorectal cancer patients treated with third line cetuximab. A predictive marker for FPT metastatic colorectal cancer patients treated with third line cetuximab will enable a reduction in the number of treated patients. Treatment only of patients with a positive marker is expected to prevent inefficient treatment which will reduce suffering for the patients and reduce unnecessary medical treatment.

Conditions

Cancer of Colon

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Metastatic colorectal cancer patients

Metastatic colorectal cancer patients receiving third line cetuximab treatment

Group Type: EXPERIMENTAL

Cetuximab

Intervention Type: DRUG

Administration of drug

Interventions

Cetuximab

Administration of drug

Intervention Type: DRUG

Other Intervention Names

Erbitux

Eligibility Criteria

Inclusion Criteria

• Men and women over 18
• Tissue diagnosis of metastatic colon cancer without operational or radiation therapy options
• No RAS mutation in tumor tissue
• Measurable disease according to RACIST criteria v1.1
• ECOG ( Eastern Cooperative Oncology Group) performance status <=2
• Life expectancy of over 3 months
• Women of fertility age not pregnant
• Ability to understand and sign and informed consent form to participate in the trial and the ability to perform the treatment and follow up required for participation in the trial
• At least three months progression free time in first line cetuximab treatment
• Disease progression according to RACIST v1.1 for first and second lines
• Third line treatment will be applied no less then 17 weeks following and of first line treatment

Exclusion Criteria

• RAS mutation carriers, or patients with uncertain metastatic colon cancer diagnosis
• Patients operated two weeks prior to accepting trail drug, or that did not recover from treatment
• Level 3 allergic response to any of trial drugs
• First line cetuximab treatment stopped due to allergic response
• Severe medical or mental diagnosis which might increase the risk in drug administration according to treating physician's discretion
• Pregnant or lactating women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Serono International SA

INDUSTRY

Sponsor Role: collaborator

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aviad Zick, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Senior medical oncologist, Head of Cancer Genetics Laboratory, Dep. of Oncology

Locations

Hadassah Ein Kerem

Jerusalem, , Israel

Countries

Israel

Other Identifiers

0436-17

Identifier Type: -

Identifier Source: org_study_id