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Monoclonal Antibodies
Cetuximab for Skin Cancer
N/A
Waitlist Available
Led By Janice Mehnert
Research Sponsored by Rutgers, The State University of New Jersey
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 2 years
Awards & highlights
Study Summary
This trial studies how well cetuximab works in treating patients with skin cancer.
Who is the study for?
This trial is for patients with aggressive, locally advanced skin cancer that hasn't spread to distant organs. Participants must be relatively fit (ECOG <=2), not pregnant, and willing to consent to treatment and biopsies. They should have a life expectancy of at least 12 weeks and cannot join if they have serious health issues, certain mineral imbalances, or allergies to cetuximab.Check my eligibility
What is being tested?
The study tests the effects of cetuximab, a monoclonal antibody targeting cancer cells when given before surgery. The goal is to see if it can shrink tumors effectively enough to reduce the amount of normal tissue removed during surgery.See study design
What are the potential side effects?
Cetuximab may cause side effects such as allergic reactions, skin rash, low magnesium levels in blood, difficulty breathing due to lung inflammation, abdominal pain from digestive tract irritation and fatigue.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response Rate of Cetuximab by RECIST Criteria
Secondary outcome measures
Downstream Activation of Signaling Pathways Without a Known Driver, Including the EGFRpathway
Overall Survival
Potential Markers of Response and/or Resistance to Cetuximab Therapy
+1 moreSide effects data
From 2012 Phase 3 trial • 3397 Patients • NCT0007927417%
Neutrophil count decreased
12%
Diarrhea
8%
Fatigue
6%
Nausea
6%
Blood glucose increased
5%
Vascular access complication
5%
Thrombosis
5%
Vomiting
3%
Dehydration
3%
Febrile neutropenia
3%
Paresthesias
3%
Laryngeal
2%
Dyspnea
2%
Ear, nose and throat examination abnormal
2%
Mucositis oral
2%
Syncope
2%
Abdominal pain
2%
Headache
2%
Hypersensitivity
1%
Myocardial ischemia
1%
Pharyngeal examination abnormal
1%
Flushing
1%
Ataxia
1%
Peripheral motor neuropathy
1%
Lymphocyte count decreased
1%
Rash desquamating
1%
Lipase increased
1%
Catheter related infection
1%
Fracture
1%
Sudden death
1%
INR increased
1%
Amylase increased
1%
Depression
1%
Colitis
1%
Epistaxis
1%
Ischemia cerebrovascular
1%
Thrombotic microangiopathy
1%
Small intestinal obstruction
1%
Serum potassium decreased
1%
Dizziness
1%
Pancreatitis
1%
Watering eyes
1%
Bronchitis
1%
Serum calcium decreased
1%
Cough
1%
Hypoxia
1%
Voice alteration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm C (Combination Chemotherapy)
Arm F (Combination Chemotherapy, Monoclonal Antibody)
Arm E (Combination Chemotherapy, Monoclonal Antibody)
Arm D (Combination Chemotherapy, Monoclonal Antibody)
Arm G (Locally Directed Therapy)
Arm B (Combination Chemotherapy)
Arm A (Combination Chemotherapy)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (cetuximab)Experimental Treatment2 Interventions
Patients receive cetuximab IV over 60-120 minutes once weekly for 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
cetuximab
2000
Completed Phase 3
~7290
Find a Location
Who is running the clinical trial?
Rutgers Cancer Institute of New JerseyOTHER
70 Previous Clinical Trials
18,742 Total Patients Enrolled
Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
64,217 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,138 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must have a negative pregnancy test.You had radiation therapy before, but your condition has gotten worse at the place where you had the radiation.Your blood potassium levels are too low or too high, even after trying to fix them.You have cancer that has spread to other parts of the body.You have another type of cancer, but treating it might affect your ability to take part in this trial.Patients must have a performance status of 2 or lower according to the Eastern Cooperative Oncology Group (ECOG) scale.Your blood calcium levels are too low or too high, even after trying to fix them.You have had allergic reactions to drugs similar to cetuximab.Your magnesium levels are too low or too high despite efforts to fix them.You have a type of skin cancer that is untreated, or has come back after treatment, and is considered to be aggressive and locally advanced based on specific criteria.Your doctor thinks you will live for at least 12 more weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (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.
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