Cetuximab Therapy for Third Line Rechallenge in Metastati... | NCT03524820

Studies
Cetuximab Therapy for Third Line Rechallenge in Metastatic Colorectal Cancer

NCT03524820

Sponsor

Hadassah Medical Organization

Status

Terminated

Last Update Posted

Aug 4, 2022Actual

Enrollment

3Actual

Phase

Phase 2

Conditions

Cancer of Colon

Interventions

Cetuximab

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

By Merck

Expanded Access Info

Start Date

Oct 17, 2017Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Mar 7, 2018

First Submission Date that Met QC Criteria

May 13, 2018

First Posted Date

May 15, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2022

Last Update Posted Date

Aug 4, 2022Actual

Name	Class
Merck Serono International SA	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Metastatic colorectal cancer patients	Experimental	Metastatic colorectal cancer patients receiving third line cetuximab treatment	Drug: Cetuximab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cetuximab	Drug	Administration of drug	Metastatic colorectal cancer patients

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Aviad Zick, MD PhD	Senior medical oncologist, Head of Cancer Genetics Laboratory, Dep. of Oncology	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Ein Kerem		Jerusalem		91120	Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins