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Cetuximab Therapy for Third Line Rechallenge in Metastatic Colorectal Cancer

Primary Purpose

Cancer of Colon

Status
Terminated
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Cetuximab
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of Colon focused on measuring cetuximab, colon cancer, RAS

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hadassah Ein Kerem

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Metastatic colorectal cancer patients

Arm Description

Metastatic colorectal cancer patients receiving third line cetuximab treatment

Outcomes

Primary Outcome Measures

response to treatment
CT based on standard RECIST criteria

Secondary Outcome Measures

Full Information

First Posted
March 7, 2018
Last Updated
August 2, 2022
Sponsor
Hadassah Medical Organization
Collaborators
Merck Serono International SA
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1. Study Identification

Unique Protocol Identification Number
NCT03524820
Brief Title
Cetuximab Therapy for Third Line Rechallenge in Metastatic Colorectal Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
By Merck
Study Start Date
October 17, 2017 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization
Collaborators
Merck Serono International SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Colon
Keywords
cetuximab, colon cancer, RAS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metastatic colorectal cancer patients
Arm Type
Experimental
Arm Description
Metastatic colorectal cancer patients receiving third line cetuximab treatment
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Other Intervention Name(s)
Erbitux
Intervention Description
Administration of drug
Primary Outcome Measure Information:
Title
response to treatment
Description
CT based on standard RECIST criteria
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aviad Zick, MD PhD
Organizational Affiliation
Senior medical oncologist, Head of Cancer Genetics Laboratory, Dep. of Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Ein Kerem
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cetuximab Therapy for Third Line Rechallenge in Metastatic Colorectal Cancer

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