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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

Must not have

Prior HER-2 targeting for treatment of colorectal cancer

Known activating mutation in exon 2, 3, 4 of KRAS/NRAS genes and in exon 15 of BRAF gene

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

No Placebo-Only Group

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.

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.

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received HER-2 targeted therapy for colorectal cancer.

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My cancer has a specific mutation in the KRAS/NRAS or BRAF gene.

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I have had severe reactions to irinotecan or similar medications.

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I have previously been treated with drugs targeting EGFR.

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I am not currently on any cancer treatments not approved in this study.

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I do not have any uncontrolled illnesses.

Timeline

Screening ~ 3 weeks3 visits

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free Survival(PFS)

Secondary study objectives

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 study objectives

ERBB2 gene

Association between HER-2 gene copy number (GCN) and response

ERBB2 gene

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2050

Pertuzumab

2014

Completed Phase 3

~7500