Cetuximab Therapy for Third Line Rechallenge in Metastatic Colorectal Cancer

NCT03524820 | Terminated Phase 2

• 1 other identifier: 0436-17
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer of Colon

Keywords

cetuximab, colon cancer, RAS

Outcome Measures

Primary Outcomes (1)

• response to treatment

  CT based on standard RECIST criteria

  5 years

Study Arms (1)

Metastatic colorectal cancer patients

EXPERIMENTAL

Metastatic colorectal cancer patients receiving third line cetuximab treatment

Drug: Cetuximab

Interventions

Cetuximab DRUG

Administration of drug

Also known as: Erbitux

Metastatic colorectal cancer patients

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hadassah Medical Organization: lead
• Merck Serono International SA: collaborator

Study Sites (1)

Hadassah Ein Kerem

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Aviad Zick, MD PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: May 15, 2018
• Study Start: October 17, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 4, 2022

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)