A Phase 2 interventional study of Cetuximab and Irinotecan Hydrochloride in Colon Adenocarcinoma, ERBB2 Gene Amplification and Rectal Adenocarcinoma, sponsored by SWOG Cancer Research Network. Completed at 798 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by SWOG Cancer Research Network · Phase 2, Interventional, and Treatment
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Among 58 studies testing cetuximab in Colonic Neoplasms — 7 open to participants now, 12 under way, 4 of them phase 3. Cetuximab · Colonic Neoplasms.
Among the 58 studies testing cetuximab in Colonic Neoplasms, this one is the 10th largest by enrollment of the 56 interventional ones that give a count, is one of 2 that started in 2017, is one of 34 in phase 2, and was the 41st registered.
2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.
Browse Colonic Neoplasms studies →7 of the 58 studies testing cetuximab in Colonic Neoplasms are open now, in 12 countries. Recruiting first, the newest first:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Sites in China
Ages 18+
Merck Sharp & Dohme LLC · Sites in United States, Argentina, Australia and 26 more countries
Ages 18+
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Sites in Italy
Ages 18+
Chinese Academy of Medical Sciences · Sites in China
Ages 18+
West China Hospital · Sites in China
Ages 18+
By country, each count listing its studies:
Cetuximab: first FDA approval 2004 (ERBITUX), first EMA approval 2004. What it is approved for, and how studies give it, is on its page →
Of the 327 Colonic Neoplasms studies recruiting now, 204 (62%) set no upper age limit and 71 (22%) stop at 75 or younger; 19 take children under 18; 34 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
58 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 39 · Phase 3 12
First in 1999; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 240 is above the median of 75 across 1,711 interventional studies indexed under Colonic Neoplasms.
Median enrollment 46 across the 56 interventional studies. Of the 39 that completed or were terminated, 16 (41%) have results posted.
This tab as a report to print or save as PDF → With an account.
4 of 58 have an industry lead sponsor. The 10 most frequent:
SWOG Cancer Research Network is the lead sponsor of 339 studies on the registry; 37 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.
11 studies in Colonic Neoplasms by SWOG Cancer Research Network: none open now, none under way, none of them phase 3. Of 10 finished, 3 (30%) have results posted.
Among the 11 studies in Colonic Neoplasms by SWOG Cancer Research Network, this one is the only one that started in 2017, is one of 6 in phase 2, and was the 11th registered.
SWOG Cancer Research Network’s Colonic Neoplasms studies by the year they started, since 1994.
None of the studies under way reaches primary completion within a year.
Among the 58 studies testing cetuximab in Colonic Neoplasms, from their registry updates:
Among SWOG Cancer Research Network’s 11 in Colonic Neoplasms:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This randomized phase II trial studies how well trastuzumab and pertuzumab work compared to cetuximab and irinotecan hydrochloride in treating patients with HER2/neu amplified colorectal cancer that has spread from where it started to other places in the body and cannot be removed by surgery. Monoclonal antibodies, such as trastuzumab and pertuzumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cetuximab and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving trastuzumab and pertuzumab may work better compared to cetuximab and irinotecan hydrochloride in treating patients with colorectal cancer.
PRIMARY OBJECTIVES:
I. To evaluate the efficacy of trastuzumab and pertuzumab (TP) (Arm 1) in HER-2 amplified metastatic colorectal cancer (mCRC) by comparing progression-free survival (PFS) on TP compared to control arm (Arm 2) of cetuximab and irinotecan hydrochloride (irinotecan) (CETIRI).
SECONDARY OBJECTIVES:
I. To evaluate the overall response rate (ORR), including confirmed complete and partial response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, in treatment Arms 1 and 2.
II. To evaluate the overall survival (OS) in treatment Arms 1 and 2. III. To evaluate the safety and toxicity of TP compared to CETIRI.
TERTIARY OBJECTIVES:
I. To estimate the rates of PFS, OS, and ORR in patients who crossover to TP (Arm 3) after disease progression on CETIRI.
II. To bank images for future retrospective analysis. III. To evaluate if HER-2/centromeric probe (CEP17) signal ratio and HER-2 gene copy number (GCN) are predictive of clinical efficacy for patients receiving TP versus CETIRI.
IV. To bank tissue and blood samples for other future correlative studies from patients enrolled on the study.
OUTLINE: Patients with HER2 gene amplification are randomized to 1 of 2 arms.
ARM I: Patients receive pertuzumab intravenously (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.
ARM II: 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.
After completion of study treatment, patients are followed up for 3 years.
Inclusion Criteria:
Mutation results:
Patients must not have been treated with any of the following prior to step 1 initial registration:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Laboratory Biomarker Analysis · Biological: Pertuzumab · Biological: Trastuzumab · Device: HER-2 testing
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.
Biological: Cetuximab · Drug: Irinotecan Hydrochloride · Other: Laboratory Biomarker Analysis · Device: HER-2 testing
Given IV
Also known as: Chimeric Anti-EGFR Monoclonal Antibody, Chimeric MoAb C225, Chimeric Monoclonal Antibody C225, Erbitux, IMC-C225
Given IV
Also known as: Campto, Camptosar, Camptothecin 11, Camptothecin-11, CPT 11, CPT-11, Irinomedac, U-101440E
Correlative studies
Given IV
Also known as: 2C4, 2C4 Antibody, MoAb 2C4, Monoclonal Antibody 2C4, Perjeta, rhuMAb2C4, RO4368451
Given IV
Also known as: ABP 980, Anti-c-ERB-2, Anti-c-erbB2 Monoclonal Antibody, Anti-ERB-2, Anti-erbB-2, Anti-erbB2 Monoclonal Antibody, Anti-HER2/c-erbB2 Monoclonal Antibody, Anti-p185-HER2, c-erb-2 Monoclonal Antibody, HER2 Monoclonal Antibody, Herceptin, Herceptin Biosimilar PF-05280014, Herceptin Trastuzumab Biosimilar PF-05280014, MoAb HER2, Monoclonal Antibody c-erb-2, Monoclonal Antibody HER2, PF-05280014, rhuMAb HER2, RO0452317, Trastuzumab Biosimilar ABP 980, Trastuzumab Biosimilar PF-05280014
Central testing of HER-2 for eligibility
Progression-free Survival(PFS)
To evaluate the efficacy of trastuzumab and pertuzumab (TP) in HER-2 amplified metastatic colorectal cancer (mCRC) by comparing progression-free survival (PFS) on TP compared to control arm of cetuximab and irinotecan (CETIRI). Progression-free survival is defined as the time from date of randomization to date of first documentation of progression. Using RECIST 1.1, progression is defined as a 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed and an absolute increase of at least 0.5 cm, unequivocal progression of non-measurable disease in the opinion of the treating physician, appearance of any new lesion/site, death due to disease without prior documentation of progression and without symptomatic deterioration (defined as, global deterioration of health status requiring discontinuation of treatment without objective evidence of progression), or death due to any cause.
Time frame: Up to 3 years post randomization
Overall Response Rate (ORR) for TP and CETIRI Treatment Arms
To evaluate the overall response rate (ORR), including confirmed complete and partial response per RECIST 1.1, in the TP and CETIRI treatment arms. Overall response rate includes complete response(CR) and partial response(PR). Complete response is defined as complete disappearance of all target and non-target lesions and no related symptoms. Partial response is defined as a greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions for patients with at least one measurable lesion.
Time frame: 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
2 Year Overall Survival (OS) for TP and CETIRI Treatment Arms
Percentage of participants still alive 2 years after the last accrual to registration step 2. Overall survival is defined as time from date of registration to date of death due to any cause. Patients last known to be alive are censored at their last contact date.
Time frame: from the date of the last accrual to registration step 2 to date of death due to any cause, up to 2 years
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs.
Routine toxicities were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0, and SAEs were evaluated according to CTCAE version 5.0. Only adverse events that are possibly, probably, or definitely related to study drug are reported.
Time frame: Duration of treatment and follow-up until death or 3 years post Step 2 Randomization.
| Milestone | Trastuzumab + Pertuzumab | Cetuximab + Irinotecan |
|---|---|---|
| Started | 26 | 28 |
| Progressed and crossed over | 0 | 20 |
| Completed | 0 | 20 |
| Not completed | 26 | 8 |
| Withdrew: Still receiving protocol treatment | 2 | 0 |
| Withdrew: Adverse event | 1 | 2 |
| Withdrew: Refusal unrelated to adverse event | 0 | 1 |
| Withdrew: Progression/relapse | 21 | 3 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Other - not protocol specified | 1 | 1 |
| Withdrew: Major protocol deviation | 0 | 1 |
| Milestone | Trastuzumab + Pertuzumab | Cetuximab + Irinotecan |
|---|---|---|
| Started | 0 | 20 |
| Completed | 0 | 0 |
| Not completed | 0 | 20 |
| Withdrew: Still receiving protocol treatment | 0 | 1 |
| Withdrew: Progression/relapse | 0 | 13 |
| Withdrew: Other - not protocol specified | 0 | 4 |
| Withdrew: Adverse event | 0 | 2 |
To evaluate the efficacy of trastuzumab and pertuzumab (TP) in HER-2 amplified metastatic colorectal cancer (mCRC) by comparing progression-free survival (PFS) on TP compared to control arm of cetuximab and irinotecan (CETIRI). Progression-free survival is defined as the time from date of randomization to date of first documentation of progression. Using RECIST 1.1, progression is defined as a 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed and an absolute increase of at least 0.5 cm, unequivocal progression of non-measurable disease in the opinion of the treating physician, appearance of any new lesion/site, death due to disease without prior documentation of progression and without symptomatic deterioration (defined as, global deterioration of health status requiring discontinuation of treatment without objective evidence of progression), or death due to any cause.
| Months | Trastuzumab + Pertuzumab | Cetuximab + Irinotecan |
|---|---|---|
| Progression-free Survival(PFS) | 4.7 (1.9 to 7.6) | 3.7 (1.6 to 6.7) |
To evaluate the overall response rate (ORR), including confirmed complete and partial response per RECIST 1.1, in the TP and CETIRI treatment arms. Overall response rate includes complete response(CR) and partial response(PR). Complete response is defined as complete disappearance of all target and non-target lesions and no related symptoms. Partial response is defined as a greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions for patients with at least one measurable lesion.
| Participants | Trastuzumab + Pertuzumab | Cetuximab + Irinotecan |
|---|---|---|
| Overall Response Rate (ORR) for TP and CETIRI Treatment Arms | 9 | 7 |
Percentage of participants still alive 2 years after the last accrual to registration step 2. Overall survival is defined as time from date of registration to date of death due to any cause. Patients last known to be alive are censored at their last contact date.
| percentage of participants | Trastuzumab + Pertuzumab | Cetuximab + Irinotecan |
|---|---|---|
| 2 Year Overall Survival (OS) for TP and CETIRI Treatment Arms | 67.1 (44.6 to 82.1) | 56.7 (35.2 to 73.5) |
Routine toxicities were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0, and SAEs were evaluated according to CTCAE version 5.0. Only adverse events that are possibly, probably, or definitely related to study drug are reported.
| Participants | Trastuzumab + Pertuzumab | Cetuximab + Irinotecan |
|---|---|---|
| Abdominal pain | 1 | 0 |
| Alanine aminotransferase increased | 1 | 0 |
| Alkaline phosphatase increased | 1 | 0 |
| Anemia | 0 | 1 |
| Anorexia | 0 | 1 |
| Atrial fibrillation | 1 | 0 |
| Diarrhea | 0 | 2 |
| Dyspnea | 1 | 0 |
| Fatigue | 0 | 2 |
| Gastrointestinal disorders - Other, specify | 0 | 2 |
| Hypokalemia | 0 | 1 |
| Hypomagnesemia | 0 | 1 |
| Infusion related reaction | 1 | 0 |
| Leukocytosis | 0 | 1 |
| Lymphocyte count decreased | 1 | 0 |
| Rash acneiform | 0 | 3 |
| Rash maculo-papular | 1 | 2 |
| Thromboembolic event | 0 | 1 |
| Vomiting | 1 | 1 |
Collected over Duration of treatment and follow up until death or 3 years post Step 2 Randomization.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Trastuzumab + Pertuzumab | 9/26 (34.6%) | 8/26 (30.8%) | 23/26 (88.5%) |
| Cetuximab + Irinotecan | 18/27 (66.7%) | 1/26 (3.8%) | 26/26 (100%) |
| Crossover: Trastuz +Pertuz | 12/20 (60%) | 5/20 (25%) | 18/20 (90%) |
| Event | Trastuzumab + Pertuzumab | Cetuximab + Irinotecan | Crossover: Trastuz +Pertuz |
|---|---|---|---|
| NauseaGastrointestinal disorders | 0/26 | 0/26 | 2/20 |
| VomitingGastrointestinal disorders | 0/26 | 0/26 | 2/20 |
| Abdominal painGastrointestinal disorders | 0/26 | 0/26 | 1/20 |
| DiarrheaGastrointestinal disorders | 0/26 | 0/26 | 1/20 |
| Papulopustular rashInfections and infestations | 0/26 | 0/26 | 1/20 |
| DehydrationMetabolism and nutrition disorders | 0/26 | 0/26 | 1/20 |
| HypokalemiaMetabolism and nutrition disorders | 0/26 | 0/26 | 1/20 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 0/26 | 0/26 | 1/20 |
| Stevens-Johnson syndromeSkin and subcutaneous tissue disorders | 0/26 | 0/26 | 1/20 |
| Atrial fibrillationCardiac disorders | 1/26 | 0/26 | 0/20 |
| Event | Trastuzumab + Pertuzumab | Cetuximab + Irinotecan | Crossover: Trastuz +Pertuz |
|---|---|---|---|
| DiarrheaGastrointestinal disorders | 15/26 | 14/26 | 11/20 |
| FatigueGeneral disorders | 9/26 | 14/26 | 10/20 |
| NauseaGastrointestinal disorders | 5/26 | 13/26 | 4/20 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 6/26 | 12/26 | 7/20 |
| HypomagnesemiaMetabolism and nutrition disorders | 2/26 | 10/26 | 2/20 |
| Rash acneiformSkin and subcutaneous tissue disorders | 1/26 | 10/26 | 5/20 |
| AnemiaBlood and lymphatic system disorders | 4/26 | 8/26 | 3/20 |
| ConstipationGastrointestinal disorders | 2/26 | 8/26 | 3/20 |
| HypokalemiaMetabolism and nutrition disorders | 5/26 | 7/26 | 3/20 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 7/26 | 7/26 | 2/20 |
| Age, Continuous(years) | Trastuzumab + Pertuzumab | Cetuximab + Irinotecan | Total |
|---|---|---|---|
| Median | 56.2 (32.1 to 83.8) | 59.1 (38.9 to 75.2) | 57.6 (32.1 to 83.8) |
| Sex: Female, Male(Participants) | Trastuzumab + Pertuzumab | Cetuximab + Irinotecan | Total |
|---|---|---|---|
| Female | 13 | 13 | 26 |
| Male | 13 | 14 | 27 |
| Race/Ethnicity, Customized(Participants) | Trastuzumab + Pertuzumab | Cetuximab + Irinotecan | Total |
|---|---|---|---|
| Hispanic — Yes | 1 | 2 | 3 |
| Hispanic — No | 23 | 25 | 48 |
| Hispanic — Unknown | 2 | 0 | 2 |
| Race/Ethnicity, Customized(Participants) | Trastuzumab + Pertuzumab | Cetuximab + Irinotecan | Total |
|---|---|---|---|
| Race — White | 19 | 21 | 40 |
| Race — Black | 1 | 4 | 5 |
| Race — Asian | 4 | 1 | 5 |
| Race — Unknown | 2 | 1 | 3 |
| Number of Participants with Prior Use of Irinotecan(Participants) | Trastuzumab + Pertuzumab | Cetuximab + Irinotecan | Total |
|---|---|---|---|
| Yes | 11 | 13 | 24 |
| No | 15 | 14 | 29 |
| HER2/CEP17 Ratio(Participants) | Trastuzumab + Pertuzumab | Cetuximab + Irinotecan | Total |
|---|---|---|---|
| >5 | 19 | 20 | 39 |
| <=5 | 7 | 7 | 14 |
Showing the first 100 of 798 sites across 2 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Nov 2017 to primary completion in Nov 2022, 59 months.
Results were first posted in Feb 2024, 1 year 3 months after primary completion.
Of 123 non-industry phase 2 interventional studies under Colonic Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 66. This study's 59 months is above that.
Counting every sponsor, half of 136 studies reached it within 43 months; a quarter within 30 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Cetuximab · Irinotecan · Pertuzumab · Trastuzumab
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