Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cetuximab Therapy for Third Line Rechallenge in Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03524820
Recruitment Status : Recruiting
First Posted : May 15, 2018
Last Update Posted : May 18, 2018
Sponsor:
Collaborator:
Merck Serono International SA
Information provided by (Responsible Party):
Hadassah Medical Organization

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.

Condition or disease Intervention/treatment Phase
Cancer of Colon Drug: Cetuximab Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 17, 2017
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : February 28, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arm Intervention/treatment
Experimental: Metastatic colorectal cancer patients
Metastatic colorectal cancer patients receiving third line cetuximab treatment
Drug: Cetuximab
Administration of drug
Other Name: Erbitux




Primary Outcome Measures :
  1. response to treatment [ Time Frame: 5 years ]
    CT based on standard RECIST criteria



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03524820


Contacts
Layout table for location contacts
Contact: Aviad Zick, MD PhD 972504048024 aviadz@hadassah.org.il
Contact: Dana Sherill-Rofe, PhD 972544709946 sherill@hadassah.org.il

Locations
Layout table for location information
Israel
Hadassah Ein Kerem Recruiting
Jerusalem, Israel, 91120
Contact: Aviad Zick, MD PhD    972504048024    aviadz@hadassah.org.il   
Contact: Jonathan Cohen, MD    972505172537    cohenjon@hadassah.org.il   
Sponsors and Collaborators
Hadassah Medical Organization
Merck Serono International SA
Investigators
Layout table for investigator information
Principal Investigator: Aviad Zick, MD PhD Senior medical oncologist, Head of Cancer Genetics Laboratory, Dep. of Oncology

Layout table for additonal information
Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT03524820     History of Changes
Other Study ID Numbers: 0436-17
First Posted: May 15, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hadassah Medical Organization:
cetuximab, colon cancer, RAS

Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents