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Monoclonal Antibodies
Panitumumab for Colorectal Cancer
Phase 2
Waitlist Available
Led By John H Strickler
Research Sponsored by Academic and Community Cancer Research United
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Absolute neutrophil count (ANC) >= 1500/mm^3 without colony stimulating factor support (obtained =< 7 days prior to randomization)
Documented wild-type in KRAS and NRAS (codons 12, 13, 59, 61, 117, and 146) and in BRAF codon 600, based on tumor tissue taken from primary or metastatic site prior to receipt of anti EGFR therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is comparing panitumumab to the standard of care for treating patients with colorectal cancer that has spread and is negative for RAS wild-type.
Who is the study for?
Adults with RAS wild-type colorectal cancer that has spread and/or can't be surgically removed, who have tried anti-EGFR therapy for at least 3 months. They must have good organ function, no major mutations in certain genes, and agree to use contraception. Excluded are those with specific gene mutations or amplifications, prior treatment with both TAS-102 and regorafenib, inability to swallow tablets, uncontrolled illnesses or conditions that could affect the trial's outcomes.Check my eligibility
What is being tested?
The trial is testing if panitumumab retreatment is more effective than standard treatments (regorafenib or TAS-102) for metastatic colorectal cancer without resistance mutations. Panitumumab may inhibit tumor growth by blocking growth factors; regorafenib might stop tumors by interfering with these factors; TAS-102 aims to kill or halt cancer cell division.See study design
What are the potential side effects?
Panitumumab can cause skin reactions and magnesium deficiency. Regorafenib may lead to hand-foot skin reactions, high blood pressure, fatigue, diarrhea. TAS-102 side effects include low blood counts leading to infections or bleeding problems as well as nausea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My white blood cell count is healthy without needing medication.
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My cancer is wild-type for KRAS, NRAS, and BRAF based on tests.
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It's been over 90 days since my last EGFR therapy before my blood test.
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I have not taken anti-VEGF drugs like bevacizumab.
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My cancer did not respond or I couldn't tolerate specific chemotherapy and targeted therapy.
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I am 18 years old or older.
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It's been over 90 days since my last EGFR therapy before my blood test.
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My colon or rectum cancer is confirmed by tests and cannot be removed by surgery.
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I have a tumor that can be measured and has not been treated with radiation, or it has grown since being radiated.
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My colon or rectum cancer is confirmed by tests and cannot be removed by surgery.
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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 am 18 years old or older.
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My cancer is wild-type for KRAS, NRAS, and BRAF based on tests from my tumor tissue.
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My cancer progressed after 3+ months of anti-EGFR treatment.
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I have been treated with a medication like 5-fluorouracil or capecitabine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival (OS)
Secondary outcome measures
Clinical benefit rate
Incidence of adverse events
Overall response rate (ORR)
+2 moreOther outcome measures
Cell free tumor deoxyribonucleic acid (cfDNA)
Circulating protein studies
Tumor tissue studies
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (panitumumab)Experimental Treatment3 Interventions
Patients receive panitumumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (regorafenib, trifluridine and tipiracil hydrochloride)Active Control4 Interventions
Patients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-12, or regorafenib PO QD on days 1-21, at the discretion of the treating physician. Treatment repeats every 28 days for a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Panitumumab
2020
Completed Phase 3
~6490
Find a Location
Who is running the clinical trial?
Academic and Community Cancer Research UnitedLead Sponsor
53 Previous Clinical Trials
5,052 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,069 Total Patients Enrolled
John H StricklerPrincipal InvestigatorAcademic and Community Cancer Research United
4 Previous Clinical Trials
351 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You had a blood test called Guardant360 within the last 90 days before starting the study.My white blood cell count is healthy without needing medication.I have a serious wound or fracture that is not healing.I am currently taking or have taken Irinotecan.I have not had severe bleeding in the last 4 weeks.I haven't needed strong heart rhythm medications in the last 6 months.My cancer is wild-type for KRAS, NRAS, and BRAF based on tests.I have recovered from previous treatment side effects, except for hair loss, nerve issues from oxaliplatin, minor electrolyte issues, or other non-serious side effects.My cancer has spread to my brain.I have not had major surgery or significant injury within the last 28 days, or 56 days for specific surgeries.I agree to use two forms of birth control, including a barrier method, during and for 2 months after the study.I have a known history of HIV, hepatitis B or C, or another serious infection needing ongoing treatment.You agree to give samples of your tissue and blood for research purposes.I agree to share my samples and data from this trial for future research.I cannot swallow pills.I have a history of lung scarring or inflammation.My blood pressure is high (>150/90 mm Hg) despite taking medication.It's been over 90 days since my last EGFR therapy before my blood test.I haven't had cancer treatment like radiation or chemotherapy in the last 3 weeks.I am not pregnant, not nursing, and willing to use contraception due to the study's risks.I have not taken anti-VEGF drugs like bevacizumab.My cancer did not respond or I couldn't tolerate specific chemotherapy and targeted therapy.My cancer has a specific gene change detected by a blood test.I am on blood thinners like warfarin.I have not used herbal remedies like St. John's wort in the last week.I am 18 years old or older.I have been treated with both TAS-102 and regorafenib.You are allergic or highly sensitive to any of the drugs used in the study, except for cetuximab.I do not have a severe ongoing infection.It's been over 90 days since my last EGFR therapy before my blood test.My colon or rectum cancer is confirmed by tests and cannot be removed by surgery.I have a tumor that can be measured and has not been treated with radiation, or it has grown since being radiated.I understand the study requirements and have signed the consent form.I have a history of bleeding or clotting disorders.You have a history of drug or alcohol abuse or any medical or mental condition that could make it difficult for you to take part in the study or could affect the study results.My colon or rectum cancer is confirmed by tests and cannot be removed by surgery.I haven't taken strong CYP3A4 drugs in the last week.I have a history of problems absorbing nutrients.My kidney function, measured by creatinine clearance, is adequate.I can take care of myself and am up and about more than half of my waking hours.My cancer's genetic test shows less than 0.5% mutation in any gene.I have been diagnosed with heart failure that affects my daily activities.I am 18 years old or older.My cancer is wild-type for KRAS, NRAS, and BRAF based on tests from my tumor tissue.If you do not have the results of your Guardant360 test available, it is highly recommended that you enroll in the ACCRU_GI-1611 (COLOMATE) study.My cancer progressed after 3+ months of anti-EGFR treatment.I am currently taking or have taken Oxaliplatin.I have been treated with a medication like 5-fluorouracil or capecitabine.I have colorectal cancer and no other untreated cancers, except for certain skin, cervical, or superficial bladder cancers.I haven't had a stroke, heart attack, or any major heart procedures in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (panitumumab)
- Group 2: Arm B (regorafenib, trifluridine and tipiracil hydrochloride)
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.
Is this clinical trial popular in the United States?
"To make participation more convenient for patients, the 17 sites running this study are located in or near major cities including Chicago, Los Angeles and Atlanta."
Answered by AI
What are the primary indications for Panitumumab?
"Panitumumab is most frequently used to treat patients that have already received oxaliplatin chemotherapy. However, it has also been known to be effective in treating conditions such as previously treated with anti-vegf, sorafenib, and metastatic colorectal cancer (crc)."
Answered by AI
How many test subjects are part of this experiment?
"Unfortunately, this study is not currently enrolling new participants. The original posting was on April 24th, 2020 with the most recent update being October 18th, 2022. If you are seeking other trials, there are presently 4398 trials actively enrolling participants with stage iiia colorectal cancer ajcc v8 and 135 studies for Panitumumab actively looking for participants."
Answered by AI
Is this research project experimental in nature?
"There are 135 ongoing studies involving panitumumab in 37 countries and 545 cities. The first study was conducted in 2011 by Amgen and involved 75 patients. The study completed Phase 2 drug approval and since then, 437 additional studies have been conducted."
Answered by AI
Is there previous research to support the use of Panitumumab?
"There are a total of 135 clinical trials currently underway for panitumumab. Of these, 13 have progressed to Phase 3 testing. Even though the majority of these studies originate from Lakewood, New jersey, there are 2108 locations running trials for this potential treatment."
Answered by AI
Can new patients still join the clinical trial?
"Unfortunately, this study is no longer actively recruiting patients. The clinical trial was first posted on 4/24/2020 and was most recently updated on 10/18/2022. However, there are presently 4398 trials actively enrolling patients with stage iiia colorectal cancer ajcc v8 and 135 trials for Panitumumab that have open enrollment."
Answered by AI
Has Panitumumab been cleared by the FDA?
"Panitumumab's safety is based on data from Phase 2 trials, which means that while there is some evidence supporting its safety, none exists for its efficacy. Consequently, our team gave it a score of 2."
Answered by AI
Who else is applying?
What site did they apply to?
Mayo Clinic in Florida
What portion of applicants met pre-screening criteria?
Met criteria
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