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Monoclonal Antibodies

Cetuximab for Colorectal Cancer (APK Mutant Trial)

Salt Lake City, UT
Phase 2
Waitlist Available
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.
Must not have
Prior use of systemic anti-EGFR therapy including cetuximab or panitumumab is not allowed but prior use irinotecan, oxaliplatin, regorafenib or TAS-102 is allowed
--Note: Brain metastases or cranial epidural disease adequately treated with radiotherapy and/or surgery and stable for at least 4 weeks before the first dose of study treatment will be allowed on trial. Subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the first dose of study treatment.
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
No Placebo-Only Group

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.

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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 below
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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)
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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.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't used anti-EGFR drugs like cetuximab or panitumumab, but I may have used irinotecan, oxaliplatin, regorafenib, or TAS-102.
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My brain metastases are stable, and I haven't needed steroids for 4 weeks.
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I have serious heart issues, including recent heart attack or uncontrolled heart problems.
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I do not have active infections like TB, hepatitis B, or hepatitis C.
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I need immediate brain-specific treatment for my cancer that has spread to the brain.
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My blood pressure is very high (>180/130 mmHg).
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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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression free survival (PFS)
Secondary study objectives
Overall survival (OS).

Side effects data

From 2012 Phase 3 trial • 73 Patients • NCT01177956
43%
Leucopenia
43%
Weight Decreased
40%
Nausea
35%
Rash
34%
Hypomagnesaemia
32%
Hypokalemia
31%
Constipation
28%
Neutropenia
28%
Vomiting
26%
Decreased Appetite
22%
Pyrexia
19%
Hyponatremia
19%
Acne
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%
Hypochloremia
7%
Dermatitis Acneiform
7%
Hypocalcaemia
7%
Abdominal Pain Upper
7%
Paronychia
7%
Aspartate Aminotransferase Increased
7%
Weight Increased
6%
Dyspnoea
6%
Oral Pain
6%
Neck pain
6%
Headache
3%
Anaphylactic reaction
1%
Tumor hemorrhage
1%
Respiratory alkalosis
1%
Pulmonary embolism
1%
Electrolyte imbalance
1%
Pneumonitis
1%
Staphylococcal skin infection
1%
Microcytic anemia
1%
Myocardial infarction
1%
Mouth hemorrhage
1%
Pneumonia
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Closest Location:Huntsman Cancer Institute at University of Utah· Salt Lake City, UT· 1514 miles

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
14,057 Previous Clinical Trials
41,149,421 Total Patients Enrolled
University of UtahLead Sponsor
1,162 Previous Clinical Trials
1,631,266 Total Patients Enrolled
Vaia Florou, MDPrincipal InvestigatorHuntsman Cancer Institute

Media Library

Cetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04853043 — Phase 2
Colorectal Cancer Research Study Groups: Cetuximab
Colorectal Cancer Clinical Trial 2023: Cetuximab Highlights & Side Effects. Trial Name: NCT04853043 — Phase 2
Cetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04853043 — Phase 2
~2 spots leftby Mar 2026
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