Cetuximab Therapy for Third Line Rechallenge in Metastatic Colorectal Cancer

Cetuximab Monotherapy or Cetuximab + Chemotherapy for Third Line Rechallenge in Metastatic Colorectal Cancer, RAS+ (RAt Sarcoma Gene) Wild Type Patients, Who Were Treated With Cetuximab Chemotherapy as First Line Treatment

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.

Study Overview

• Status: Terminated
• Conditions: Cancer of Colon
• Intervention / Treatment: Drug: Cetuximab

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91120
    • Hadassah Ein Kerem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Metastatic colorectal cancer patients; Metastatic colorectal cancer patients receiving third line cetuximab treatment	Drug: Cetuximab; Administration of drug; Other Names: Erbitux

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
response to treatment	CT based on standard RECIST criteria	5 years

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Collaborators: Merck Serono International SA
• Investigators: Principal Investigator: Aviad Zick, MD PhD, Senior medical oncologist, Head of Cancer Genetics Laboratory, Dep. of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2017
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: March 7, 2018
• First Submitted That Met QC Criteria: May 13, 2018
• First Posted (Actual): May 15, 2018

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: cetuximab, colon cancer, RAS
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cetuximab
• Other Study ID Numbers: 0436-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No