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Monoclonal Antibodies
Anti-EGFR Therapy for Colorectal Cancer
Phase 2
Recruiting
Led By Dustin Deming, MD
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
Participants must have no metastatic cancer lesions greater than 3.5cm in diameter. Any number of metastatic lesions will be allowed
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will study whether using higher doses of panitumumab or cetuximab can better treat unresectable colorectal cancer in 110 people.
Who is the study for?
This trial is for adults with left-sided, unresectable metastatic colorectal cancer (mCRC) who haven't had major surgery in the last 2 weeks and have no other cancers needing treatment. They should not have large mCRC lesions (>3.5cm), must show stable organ function, and agree to use contraception if of childbearing potential. Participants can be new to treatment or may have previously responded to EGFR inhibitors.
What is being tested?
The study tests established doses of panitumumab or cetuximab for treating mCRC, aiming to maximize benefits from blocking the epidermal growth factor receptor (EGFR). It's a strategy trial enrolling up to 110 patients who will receive treatments over a period that could extend up to five years.
What are the potential side effects?
Panitumumab and cetuximab can cause skin reactions, low magnesium levels, fatigue, diarrhea, and infusion-related reactions like fever or chills. Rarely they might lead to severe lung problems or allergic responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has spread, but no single spot is larger than 3.5cm.
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I can take care of myself and am up and about more than half of my waking hours.
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I had brain metastasis but finished treatment over 4 weeks ago, am off steroids for 2 weeks, and have no symptoms.
Select...
My colorectal cancer has spread and was confirmed by tests.
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My tumor is MMR proficient.
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I have no allergies to panitumumab, cetuximab, or similar drugs.
Select...
My colorectal cancer has spread and started after the splenic flexure.
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My cancer is not highly variable at the genetic level.
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I have not had any major surgery in the last 2 weeks.
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My kidney function, measured by creatinine or GFR, is within the normal range.
Select...
My cancer cells show normal MMR protein activity.
Select...
My cancer is not highly variable at the genetic level.
Select...
My cancer shows normal MMR protein levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cohort C Progression Free Survival (PFS)
Disease Control Rate (DCR) at 6 months for Cohorts A and B
Secondary study objectives
Cohort A and B Progression Free Survival (PFS)
Cohort A, B, and C Objective Response Rate (ORR)
Cohort A, B, and C Overall Survival (OS)
+2 moreOther study objectives
Change in Participant Derived Organotypic Spheroid Response over baseline
Circulating Tumor DNA (ctDNA) at time of Progression
Side effects data
From 2009 Phase 3 trial • 463 Patients • NCT0011376366%
ERYTHEMA
58%
PRURITUS
57%
DERMATITIS ACNEIFORM
28%
ANOREXIA
26%
FATIGUE
25%
PARONYCHIA
24%
ABDOMINAL PAIN
22%
RASH
22%
NAUSEA
21%
DIARRHOEA
20%
SKIN FISSURES
19%
CONSTIPATION
18%
EXFOLIATIVE RASH
18%
VOMITING
16%
PYREXIA
16%
DYSPNOEA
15%
COUGH
14%
ACNE
13%
COLORECTAL CANCER METASTATIC
12%
OEDEMA PERIPHERAL
12%
ASTHENIA
10%
BACK PAIN
10%
NAIL DISORDER
10%
DRY SKIN
9%
SKIN EXFOLIATION
8%
ABDOMINAL PAIN UPPER
7%
INSOMNIA
7%
COLORECTAL CANCER
7%
STOMATITIS
6%
SKIN ULCER
6%
GENERAL PHYSICAL HEALTH DETERIORATION
6%
GROWTH OF EYELASHES
6%
MUCOSAL INFLAMMATION
6%
JAUNDICE
6%
ANXIETY
5%
HEPATOMEGALY
5%
WEIGHT DECREASED
5%
INTESTINAL OBSTRUCTION
5%
ANAEMIA
2%
ASCITES
2%
HEPATIC FAILURE
2%
DEHYDRATION
1%
COMA
1%
GASTROINTESTINAL OBSTRUCTION
1%
RECTAL HAEMORRHAGE
1%
HYPERBILIRUBINAEMIA
1%
CACHEXIA
1%
METASTASES TO LIVER
1%
METASTASES TO LUNG
1%
HEMIPARESIS
1%
EPILEPSY
1%
DEPRESSED LEVEL OF CONSCIOUSNESS
1%
HEPATIC ENCEPHALOPATHY
1%
PULMONARY EMBOLISM
1%
DEEP VEIN THROMBOSIS
1%
JUGULAR VEIN THROMBOSIS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Panitumumab Plus BSC
BSC Alone
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort C: RechallengeExperimental Treatment4 Interventions
Participants with prior FOLFOX and either no prior EGFR inhibitor or treated on Cohort A.
Alternating Panitumumab (6mg/kg) or Cetuximab 500mg (per treating physician) and 4 cycles of FOLFIRI +/- bevacizumab
Group II: Cohort B: RetreatmentExperimental Treatment3 Interventions
Participants with treatment refractory disease who have previously benefitted (greater than or equal to 4 months ago) from anti-EGFR therapy.
Panitumumab (6mg/kg) or Cetuximab 500mg (per treating physician) on day 1 and 15 of a 28-day cycle, +/- Irinotecan (180mg/m\^2) every 2 two weeks per standard of care
Group III: Cohort A: No Previous EGFRExperimental Treatment2 Interventions
Participant who have not be previously exposed to anti-EGFR therapies and are in the first or second-line metastatic treatment setting.
Panitumumab (6mg/kg) or Cetuximab 500mg (per treating physician) on day 1 and 15 of a 28-day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FOLFIRI Protocol
2014
Completed Phase 2
~50
Bevacizumab
2013
Completed Phase 4
~5540
Irinotecan
2017
Completed Phase 3
~2590
Cetuximab
2011
Completed Phase 3
~2480
Panitumumab
2017
Completed Phase 3
~7150
Find a Location
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,231 Previous Clinical Trials
3,199,814 Total Patients Enrolled
Doris Duke Charitable FoundationOTHER
64 Previous Clinical Trials
264,339 Total Patients Enrolled
Dustin Deming, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
2 Previous Clinical Trials
48 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My recent tests show my organs are functioning well.My cancer has spread, but no single spot is larger than 3.5cm.My cancer has spread, but no single spot is larger than 3.5cm.I agree to use two forms of birth control or abstain from sex during and 120 days after treatment.I have not had any major surgery in the last 2 weeks.I can take care of myself and am up and about more than half of my waking hours.My cancer can be tracked using specific criteria but doesn't need to be measurable.I had brain metastasis but finished treatment over 4 weeks ago, am off steroids for 2 weeks, and have no symptoms.I can follow the study's procedures for its duration.My recent tests show my organs are functioning well.My colorectal cancer has spread and was confirmed by tests.I had stable disease on a previous EGFR inhibitor treatment for at least 4 months.My tumor is MMR proficient.I am not pregnant, not breastfeeding, and if of childbearing age, I have had a negative pregnancy test recently.I am not pregnant, not breastfeeding, and if of childbearing age, I am not fertile.I have no allergies to panitumumab, cetuximab, or similar drugs.I am seeking treatment for my first or second round of metastatic cancer.My cancer is not highly variable at the genetic level.I have not had any major surgery in the last 2 weeks.I've been stable on a previous EGFR inhibitor treatment for at least 4 months.My kidney function, measured by creatinine or GFR, is within the normal range.I agree to use two effective birth control methods or abstain from sex during and for 120 days after treatment.I don't have another cancer needing treatment, except if it's breast or prostate cancer treated with hormones.My colorectal cancer has spread and started after the splenic flexure.My cancer cells show normal MMR protein activity.I don't need systemic treatment for another cancer. Hormone treatment for breast or prostate cancer is okay.I am seeking treatment for my first or second round of metastatic cancer.I had brain metastasis but finished treatment over 4 weeks ago, am off steroids for 2 weeks, and have no symptoms.My cancer is not highly variable at the genetic level.My cancer shows normal MMR protein levels.I understand and can follow the study's procedures.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort C: Rechallenge
- Group 2: Cohort B: Retreatment
- Group 3: Cohort A: No Previous EGFR
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.
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