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Monoclonal Antibodies

Trastuzumab + Pertuzumab vs. Cetuximab + Irinotecan for Colorectal Cancer

Phase 2
Waitlist Available
Led By Kanwal Raghav
Research Sponsored by Southwest Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must not have had history of severe toxicity and intolerance to or hypersensitivity to irinotecan or any other study drug; patients must not have had a severe infusion-related reaction during any prior therapy with pertuzumab or trastuzumab
Measurable disease that is metastatic or locally advanced and unresectable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline, through duration of treatment (once per cycle while on treatment), and every 8 weeks after treatment until progression, up to 3 years after the last accrual to registration step 2
Awards & highlights

Study Summary

This trial studies trastuzumab and pertuzumab compared to cetuximab and irinotecan hydrochloride in treating patients with HER2/neu amplified colorectal cancer.

Who is the study for?
This trial is for adults with HER2/neu amplified colorectal cancer that's spread and can't be surgically removed. They must have had one prior chemotherapy, no severe reactions to the study drugs or similar treatments, no other cancers within two years (except certain skin cancers), and not be pregnant. Participants need a good performance status, adequate organ function, controlled brain metastases if present, and use effective contraception.Check my eligibility
What is being tested?
The trial compares two treatments: trastuzumab plus pertuzumab versus cetuximab with irinotecan hydrochloride in patients with advanced colorectal cancer. It aims to see which combination is more effective at stopping tumor growth by either killing cancer cells or preventing them from dividing and spreading.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the monoclonal antibodies (trastuzumab/pertuzumab) or chemotherapy drug (irinotecan). These could range from mild infusion-related symptoms to severe organ inflammation. Other common side effects might involve fatigue, digestive issues like diarrhea, low blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not had severe reactions to cancer drugs like irinotecan, pertuzumab, or trastuzumab.
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My cancer has spread or grown to a point where surgery can't remove it.
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My colon or rectum cancer has spread and cannot be removed by surgery.
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My cancer does not have specific genetic changes in KRAS, NRAS, or BRAF genes.
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I have not used drugs targeting EGFR for my condition.
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I've had trastuzumab or pertuzumab for breast cancer before my advanced colorectal cancer.
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My tumor slides are available for HER-2 testing by a central lab.
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I have not received HER-2 targeted treatments for my colorectal cancer.
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My cancer has been confirmed to have high levels of HER-2.
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My colon or rectum cancer has spread and cannot be removed by surgery.
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My cancer does not have specific genetic mutations in KRAS/NRAS or BRAF genes.
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I have not been treated with any drugs targeting EGFR.
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I have had at least one chemotherapy treatment for my advanced cancer that cannot be surgically removed.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I can provide slides of my tumor for HER-2 testing.
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My cancer was tested for specific mutations in a certified lab.
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I have never had a severe reaction to irinotecan or similar medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline, through duration of treatment (once per cycle while on treatment), and every 8 weeks after treatment until progression, up to 3 years after the last accrual to registration step 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline, through duration of treatment (once per cycle while on treatment), and every 8 weeks after treatment until progression, up to 3 years after the last accrual to registration step 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free Survival(PFS)
Secondary outcome measures
2 Year Overall Survival (OS) for TP and CETIRI Treatment Arms
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs.
Overall Response Rate (ORR) for TP and CETIRI Treatment Arms
Other outcome measures
ERBB2 gene
Association between HER-2 gene copy number (GCN) and response
ERBB2 gene
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II (cetuximab, irinotecan hydrochloride)Experimental Treatment4 Interventions
Patients receive cetuximab IV over 60-120 minutes and irinotecan hydrochloride IV over 90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may optionally crossover to Arm I.
Group II: Arm I (pertuzumab, trastuzumab)Experimental Treatment4 Interventions
Patients receive pertuzumab IV over 30-60 minutes and trastuzumab IV over 30-120 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan Hydrochloride
2010
Completed Phase 3
~1940
Pertuzumab
2014
Completed Phase 3
~7500
Trastuzumab
2014
Completed Phase 4
~5190
Cetuximab
2011
Completed Phase 3
~2480

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
262,011 Total Patients Enrolled
SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
265,370 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,406 Total Patients Enrolled

Media Library

Cetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03365882 — Phase 2
HER2 Gene Amplification Research Study Groups: Arm I (pertuzumab, trastuzumab), Arm II (cetuximab, irinotecan hydrochloride)
HER2 Gene Amplification Clinical Trial 2023: Cetuximab Highlights & Side Effects. Trial Name: NCT03365882 — Phase 2
Cetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03365882 — Phase 2

Frequently Asked Questions

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

Are the protocols for HER-2 testing approved by the Federal Drug Administration?

"While there exists some evidence that HER-2 testing is secure, the lack of data validating its efficacy necessitates a score of 2."

Answered by AI

What is the current size of the participant cohort in this investigation?

"This research is not currently enrolment patients. Initially posted on October 9th 2017, and last edited May 9th 2022; thus alternative studies need to be considered. There are 4310 trials which involve adenocarcinoma presently actively recruiting as well as 545 studies for HER-2 testing that are open for participants."

Answered by AI

In what contexts is PER-2 testing typically utilized?

"HER-2 testing is typically a tool for handling small cell lung cancer (sclc) but can also be utilized to combat colorectal carcinoma, ovarian cancer and sarcoma."

Answered by AI

Has there been any prior research conducted on the efficacy of HER-2 testing?

"The initial research on HER-2 testing transpired at Ospedale di Circolo e Fondazione Macchi in 1999, and to date there are 1742 trials that have been completed. Currently, 545 clinical studies are underway across the world with significant activity occuring in Bremerton, Washington."

Answered by AI

Are researchers currently accepting new participants for this experiment?

"This trial is no longer actively recruiting patients, with the latest update dated to May 9th 2022. If you are in search of other clinical trials related to adenocarcinoma there are 4355 available and 545 for HER-2 testing."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
~33 spots leftby Mar 2025