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Cetuximab for Head and Neck Cancers

Phase 2
Waitlist Available
Led By Justine Bruce
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 months
Awards & highlights

Study Summary

This study is evaluating whether a protein called AXL may be a biomarker for predicting how well a drug will work for head and neck cancer.

Eligible Conditions
  • Head and Neck Cancers
  • Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Tumor Size
Objective Tumor Response Rate - AXL Expression
Secondary outcome measures
Number of Hospital Re-admission for CTX-related Complications
Other outcome measures
Change in Ki67 From Pre- vs Post-CTX Treated Tumors
Correlation of Measures of Putative Markers of CTX Sensitivity

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%
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: Pre-Operative Cetuximab TherapyExperimental Treatment1 Intervention
Two weekly doses of pre-operative cetuximab during the interval between diagnostic HNSCC biopsy and surgery (~14 days), ensuring that no delay in standard of care (SOC) will occur. For dose #1, participants will receive cetuximab 400 mg/m2 via intravenous infusion over 2 hours (maximum infusion rate 10 mg/min) as per the standard of care loading regimen for cetuximab monotherapy. For dose #2, participants will receive cetuximab 250 mg/m2 via intravenous infusion over 1 hour (maximum infusion rate 10 mg/min) as per the standard of care dosing regimen for cetuximab monotherapy.
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?

National Institute of Dental and Craniofacial Research (NIDCR)NIH
300 Previous Clinical Trials
848,329 Total Patients Enrolled
University of Wisconsin, MadisonLead Sponsor
1,187 Previous Clinical Trials
3,169,482 Total Patients Enrolled
American Cancer Society, Inc.OTHER
224 Previous Clinical Trials
110,440 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Cetuximab in Head and Neck Cancer Patients
2019. "Cetuximab in Head and Neck Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03769311.
~2 spots leftby Apr 2025
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