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Cetuximab Therapy for Third Line Rechallenge in Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT03524820
Recruitment Status : Recruiting
First Posted : May 15, 2018
Last Update Posted : September 11, 2019
Sponsor:
Collaborator:
Merck Serono International SA
Information provided by (Responsible Party):
Hadassah Medical Organization

Tracking Information
First Submitted Date  ICMJE March 7, 2018
First Posted Date  ICMJE May 15, 2018
Last Update Posted Date September 11, 2019
Actual Study Start Date  ICMJE October 17, 2017
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2018)
response to treatment [ Time Frame: 5 years ]
CT based on standard RECIST criteria
Original Primary Outcome Measures  ICMJE
 (submitted: May 13, 2018)
response to treatment [ Time Frame: 5 years ]
CT
Change History Complete list of historical versions of study NCT03524820 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cetuximab Therapy for Third Line Rechallenge in Metastatic Colorectal Cancer
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cancer of Colon
Intervention  ICMJE Drug: Cetuximab
Administration of drug
Other Name: Erbitux
Study Arms  ICMJE Experimental: Metastatic colorectal cancer patients
Metastatic colorectal cancer patients receiving third line cetuximab treatment
Intervention: Drug: Cetuximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 13, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Aviad Zick, MD PhD 972504048024 aviadz@hadassah.org.il
Contact: Dana Sherill-Rofe, PhD 972544709946 sherill@hadassah.org.il
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03524820
Other Study ID Numbers  ICMJE 0436-17
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hadassah Medical Organization
Study Sponsor  ICMJE Hadassah Medical Organization
Collaborators  ICMJE Merck Serono International SA
Investigators  ICMJE
Principal Investigator: Aviad Zick, MD PhD Senior medical oncologist, Head of Cancer Genetics Laboratory, Dep. of Oncology
PRS Account Hadassah Medical Organization
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP