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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

Study 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.Check my eligibility

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.See study design

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 below

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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.

Select...

My tumor is MMR proficient.

Select...

I have no allergies to panitumumab, cetuximab, or similar drugs.

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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.

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My cancer cells show normal MMR protein activity.

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My cancer is not highly variable at the genetic level.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cohort C Progression Free Survival (PFS)

Disease Control Rate (DCR) at 6 months for Cohorts A and B

Secondary outcome measures

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 more

Other outcome measures

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 • NCT00113763

66%

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

SKIN EXFOLIATION

ABDOMINAL PAIN UPPER

INSOMNIA

COLORECTAL CANCER

STOMATITIS

SKIN ULCER

GENERAL PHYSICAL HEALTH DETERIORATION

GROWTH OF EYELASHES

MUCOSAL INFLAMMATION

JAUNDICE

ANXIETY

HEPATOMEGALY

WEIGHT DECREASED

INTESTINAL OBSTRUCTION

ANAEMIA

ASCITES

HEPATIC FAILURE

DEHYDRATION

COMA

GASTROINTESTINAL OBSTRUCTION

RECTAL HAEMORRHAGE

HYPERBILIRUBINAEMIA

CACHEXIA

METASTASES TO LIVER

METASTASES TO LUNG

HEMIPARESIS

EPILEPSY

DEPRESSED LEVEL OF CONSCIOUSNESS

HEPATIC ENCEPHALOPATHY

PULMONARY EMBOLISM

DEEP VEIN THROMBOSIS

JUGULAR VEIN THROMBOSIS

100%

80%

60%

40%

20%

Study treatment Arm

Panitumumab Plus BSC

BSC Alone

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

Irinotecan

2017

Completed Phase 4

~2680

Bevacizumab

2013

Completed Phase 4

~5280

Cetuximab

2011

Completed Phase 3

~2480

Panitumumab

2020

Completed Phase 3

~6490

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,189 Previous Clinical Trials

3,169,473 Total Patients Enrolled

Doris Duke Charitable FoundationOTHER

61 Previous Clinical Trials

260,015 Total Patients Enrolled

Dustin Deming, MDPrincipal InvestigatorUniversity of Wisconsin, Madison

1 Previous Clinical Trials

25 Total Patients Enrolled

Media Library

Cetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04587128 — Phase 2

Colorectal Cancer Research Study Groups: Cohort B: Retreatment, Cohort C: Rechallenge, Cohort A: No Previous EGFR

Colorectal Cancer Clinical Trial 2023: Cetuximab Highlights & Side Effects. Trial Name: NCT04587128 — Phase 2

Cetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04587128 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have there been any other initiatives to research Panitumumab?

"Currently, there are 374 active studies exploring the effectiveness of Panitumumab with 75 in Phase 3. Although a few trials for this medication take place in Pittsburgh, Pennsylvania, an expansive 12394 sites additionally offer clinical trials involving Panitumumab."

Answered by AI

Is enrollment currently available for this clinical trial?

"According to clinicaltrials.gov, this medical trial is still recruiting participants and has been since October 19th 2020. The page was last edited on September 13th 2022."

Answered by AI

Has Panitumumab obtained the regulatory green light from the FDA?

"Limited safety data exists for panitumumab, making the risk assessment score 2. Thus far, no evidence has been discovered that confirms its efficacy in treating any condition."

Answered by AI

What goals is this clinical trial aiming to accomplish?

"This research project, with assessments planned over a four-year period, aims to evaluate Cohort A's Objective Response Rate (ORR). Secondary objectives involve evaluating the Type and Severity of Toxicities according to CTCAE criteria in tabular format; Overall Survival (OS); and Cohort B's Objective Response Rate (ORR), which will incorporate all confirmed complete responses (CR) and partial responses (PR) determined by RECIST v1.1 for metastatic left-sided non-bulky colorectal cancer patients on panitumumab treatment."

Answered by AI

How many participants have signed up for the experiment?

"Affirmative. According to clinicaltrials.gov, this medical trial is still actively searching for participants since its inception on October 19th 2020 and most recent edit on September 13th 2022. 110 individuals are needed from 1 site alone."

Answered by AI

What applications is Panitumumab commonly employed for?

"Panitumumab is traditionally prescribed to treat cancerous growths. It may also be used in the management of pancreatic neoplasms, metastatic tumours, and radiation therapy-related illnesses."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Early-Line Anti-EGFR Therapy to Facilitate Retreatment for Select Patients With mCRC

2020. "Early-Line Anti-EGFR Therapy to Facilitate Retreatment for Select Patients With mCRC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04587128.

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