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Monoclonal Antibodies
Cetuximab for Colorectal Cancer
Phase 2
Recruiting
Led By Vaia Florou, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate organ function as defined as: Hematologic: Absolute neutrophil count (ANC) ≥ ≥1000/µL, Platelet count ≥ 100,000/mm3, Hemoglobin ≥ 9 g/dL, Hepatic: Total Bilirubin ≤ 1.5 mg/dL (25.65 μmol/L), Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 times the upper limit of normal (ULN; or 5.0 times the ULN in the setting of liver metastases), Renal: Serum creatinine ≤1.5 times the ULN, or creatinine clearance (measured via 24-hour urine collection) ≥40 mL/minute (that is, if serum creatinine is >1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed)
ECOG Performance Status ≤ 2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up os will be measured from the date of first dose of study drug until death from any cause. follow up for up to 5 years
Awards & highlights
Study Summary
This trial found that the EGFR inhibitor, Cetuximab, was effective in treating patients with mCRC who had mutations in the APC, TP53, and RAS genes.
Who is the study for?
Adults with metastatic colorectal cancer that has specific mutations (APC, TP53, RAS) and who have already tried at least two other treatments can join this trial. They should be relatively healthy otherwise, not pregnant or breastfeeding, and willing to use contraception.Check my eligibility
What is being tested?
The study is testing Cetuximab's effectiveness for patients with certain genetic mutations in their cancer. It's a phase II trial involving 21 people across multiple centers to see how well it works after other treatments have failed.See study design
What are the potential side effects?
Cetuximab may cause skin reactions, low magnesium levels, infusion-related reactions like fever or chills, and rarely more serious effects on the lungs or heart. Side effects vary from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and perform daily activities.
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My kidney function, measured by creatinine levels, is within the required range.
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I have had surgery for sterilization (removal of ovaries or uterus).
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I am not pregnant or I have been through menopause.
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I went through menopause due to chemotherapy over a year ago.
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I've had side effects or my cancer progressed after treatments including 5-FU, oxaliplatin, and irinotecan.
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I have had surgery for sterilization.
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My colorectal cancer has mutations in APC, TP53, and KRAS genes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ os will be measured from the date of first dose of study drug until death from any cause. follow up for up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~os will be measured from the date of first dose of study drug until death from any cause. follow up for up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival (PFS)
Secondary outcome measures
Overall survival (OS).
Side effects data
From 2012 Phase 3 trial • 73 Patients • NCT0117795643%
Leucopenia
43%
Weight Decreased
40%
Nausea
35%
Rash
34%
Hypomagnesaemia
32%
Hypokalemia
31%
Constipation
28%
Vomiting
28%
Neutropenia
26%
Decreased Appetite
22%
Pyrexia
19%
Acne
19%
Hyponatremia
19%
Hemoglobin Decreased
18%
Stomatitis
18%
Diarrhea
15%
Fatigue
15%
Pruritus
13%
Mucosal Inflammation
13%
Neutrophil Count Decreased
12%
Mouth Ulceration
10%
Insomnia
10%
Thrombocytopenia
10%
Asthenia
9%
Cough
9%
Dizziness
9%
White Blood Cell Count Decreased
7%
Dermatitis Acneiform
7%
Hypocalcaemia
7%
Hypochloremia
7%
Abdominal Pain Upper
7%
Paronychia
7%
Aspartate Aminotransferase Increased
7%
Weight Increased
6%
Neck pain
6%
Dyspnoea
6%
Oral Pain
6%
Headache
3%
Anaphylactic reaction
1%
Respiratory alkalosis
1%
Pneumonia
1%
Pulmonary embolism
1%
Microcytic anemia
1%
Myocardial infarction
1%
Pneumonitis
1%
Electrolyte imbalance
1%
Mouth hemorrhage
1%
Staphylococcal skin infection
1%
Tumor hemorrhage
1%
Toxic encephalopathy
1%
Venous thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cetuximab + Cisplatin + 5-FU : Treatment Emergent Phase
Cetuximab + Cisplatin + 5-FU : Late Phase
Trial Design
1Treatment groups
Experimental Treatment
Group I: CetuximabExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
2011
Completed Phase 3
~2480
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,664 Total Patients Enrolled
Vaia Florou, MDPrincipal InvestigatorHuntsman Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is normal.My organs are functioning well.My brain metastases are treated and stable.My liver is functioning properly.I agree to use a condom during sex for the study duration and 12 months after.I don't have another cancer that could affect this study's treatment.I am a woman aged 50 years or older.I can take care of myself and perform daily activities.I haven't used anti-EGFR drugs like cetuximab or panitumumab, but I may have used irinotecan, oxaliplatin, regorafenib, or TAS-102.I have HIV with a detectable viral load in the last 6 months.I am on effective HIV treatment with an undetectable viral load.I had hepatitis B but it's resolved, or I have hepatitis C but no active virus.My brain metastases are stable, and I haven't needed steroids for 4 weeks.I agree to use effective birth control during and for 12 months after the study.My kidney function, measured by creatinine levels, is within the required range.I am willing and able to sign the consent form for the trial.I have serious heart issues, including recent heart attack or uncontrolled heart problems.I have recovered from previous cancer treatment side effects, or they are mild.I do not have active infections like TB, hepatitis B, or hepatitis C.I am a woman under 50 years old.I have had surgery for sterilization (removal of ovaries or uterus).I am not pregnant or I have been through menopause.I need immediate brain-specific treatment for my cancer that has spread to the brain.I haven't had any vaccines except for COVID-19 in the last 4 weeks.I am 18 years old or older.I went through menopause due to chemotherapy over a year ago.I had menopause due to radiation over a year ago.I've had side effects or my cancer progressed after treatments including 5-FU, oxaliplatin, and irinotecan.I have had surgery for sterilization.I do not have any severe ongoing illnesses.My blood pressure is very high (>180/130 mmHg).I am mentally and physically able to participate in and complete the study.My colorectal cancer has mutations in APC, TP53, and KRAS genes.
Research Study Groups:
This trial has the following groups:- Group 1: Cetuximab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are part of this research endeavor?
"Affirmative. Records conserved on clinicaltrials.gov demonstrate that the trial, posted initially on November 3rd 2021 is actively recruiting candidates. 21 people are anticipated to join from two distinct medical centres."
Answered by AI
What purpose does Cetuximab usually serve in medical treatment?
"Cetuximab is often used to manage pharmacotherapy and it has proven effective against regionally advanced squamous cell carcinoma of the head and neck, metastatic hnscc, as well as other forms of squamous cell carcinoma."
Answered by AI
Is there still availability for participants in this experiment?
"Affirmative. As per the clinicaltrials.gov entry, this trial is actively recruiting participants with 21 volunteers being sought from 2 different medical centres. This posting was first made on November 3rd 2021 and has since been updated as of May 3rd 2022."
Answered by AI
Are there any previous studies that have explored the use of Cetuximab?
"Presently, 122 clinical trials are running that involve the drug Cetuximab. Of these, 30 have entered Phase 3 of testing and there is a total of 5560 sites hosting studies related to this treatment. The majority of investigations are taking place in Dresden, Arizona."
Answered by AI
Has Cetuximab obtained regulatory affirmation from the FDA?
"Cetuximab has been evaluated in a Phase 2 clinical trial, so it merits a score of two due to limited efficacy data but some supporting safety."
Answered by AI
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