Colorectal NeoplasmNCT01074333
An Observational Study of Erbitux® in Patients With Metastatic Colorectal Cancer (mCRC) Refractory to Irinotecan-containing Treatment
An observational study of Colorectal Neoplasm, run by Merck KGaA, Darmstadt, Germany at 1 site in South Korea.
Trial summary
This is an observational, non-interventional, uncontrolled, multicentric safety study in subjects with epidermal growth factor receptor (EGFR)-expressing, V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) wild-type mCRC. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Neoplasm
- What is being tested?
- Cetuximab
- Type of treatment
- Injection or infusion
- How many people
- 146 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2008to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects with EGFR-expressing, KRAS wild-type mCRC undergoing treatment with Erbitux in Korea.
Who may be able to join
- Subjects who are eligible for Erbitux treatment according to the indication in the national label of Erbitux (i.e. in EGFR expressing, KRAS wild-type metastatic colorectal adenocarcinoma).
- Subjects who have failed oxaliplatin and irinotecan-based therapy and who are intolerant to irinotecan in mCRC.
- Subjects who have signed the informed consent form
Who cannot join
- Subjects who do not fall under the approved indications according to the national label of Erbitux.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Multicenter, Observational Study on Erbitux® (Cetuximab) in Patients With EGFR-expressing, KRAS Wild-type Metastatic Colorectal Cancer
This is an observational, non-interventional, uncontrolled, multicentric safety study in subjects with epidermal growth factor receptor (EGFR)-expressing, V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) wild-type mCRC. The study aims to collect safety data related to Erbitux treatment from a total of at least 400 mCRC subjects from about 35 institutions from the start of treatment with Erbitux until progressive disease, Erbitux-related intolerable toxicities, death, or withdrawal of Erbitux treatment (whichever occurs first).
Read the detailed description
Colorectal cancer is the fourth commonest form of cancer worldwide and remains a leading malignancy both in incidence and mortality. Erbitux is an immunoglobulin G1 monoclonal antibody that specifically blocks ligand binding to the EGFR with high affinity, thereby preventing downstream signal transduction and cellular responses. Erbitux enhances the effects of some common chemotherapy agents and radiotherapy and demonstrates minimal overlapping toxicities with these approaches. Erbitux in combination with other treatment modalities, has also shown efficacy in the treatment of a number of solid tumors, including mCRC, squamous cell carcinoma of the head and neck, and non-small cell lung cancer. Based on several studies conducted in the past, Erbitux has been approved for the treatment of subjects with EGFR-expressing, KRAS wild-type mCRC, as a single agent in subjects who have failed oxaliplatin-and irinotecan-based therapy and who are intolerant to irinotecan or in combination with chemotherapy. The most common Erbitux-related adverse events (AEs) are related to skin, infusion, and hypersensitivity reactions. Other side effects with Erbitux monotherapy include asthenia, dyspnoea, mucositis, nausea, pain, fever and headache.
OBJECTIVES
Primary objective:
- To obtain safety information on the use of Erbitux in subjects with EGFR-expressing, KRAS wild-type mCRC in terms of frequency and severity of AEs
Secondary objective:
- To gather clinical efficacy information of the treatment
The study will primarily collect safety data related to Erbitux treatment along with the clinical efficacy information from the start of treatment with Erbitux until progressive disease, Erbitux related intolerable toxicities, death, or withdrawal of Erbitux treatment whichever occurs first. All subjects will be enrolled in the order to visit the physician after making contract and each subject will be observed for a period of 4 months in average. Erbitux will be prescribed to mCRC subjects according to the approved national label as in routine clinical practice under the supervision of an investigator experienced in the use of antineoplastic medicinal products. Prior to the first infusion, subjects will receive pre-medication with an antihistamine and a corticosteroid. The initial dose of Erbitux is 400 mg/m2 body surface area and the subsequent weekly doses are 250 mg/m2 each administered intravenously (i.v.) via in-line filtration with an infusion pump, gravity drip, or a syringe pump. The recommended infusion period for the initial dose is 120 minutes and for the subsequent weekly doses is 60 minutes with the maximum infusion rate not exceeding 5 ml/min. The observational period of this study is defined as from the first infusion of Erbitux until 28 days after the last infusion of Erbitux in each subject, regardless the reason of discontinuation of Erbitux treatment.
- Conditions
- Colorectal Neoplasm
- Being tested
- Cetuximab
- Keywords
- Colorectal cancer, Metastasis, Cetuximab, Erbitux, Epidermal growth factor receptor
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Also called Erbitux
In subjects with mCRC, cetuximab will be used in combination with chemotherapy or as a single agent according to the approved national label as in routine clinical practice. The initial dose of Erbitux is 400 mg/m2 body surface area and the subsequent weekly doses are 250 mg/m2 each administered i.v. via in-line filtration with an infusion pump, gravity drip, or a syringe pump. The recommended infusion period for the initial dose is 120 minutes and for the subsequent weekly doses is 60 minutes with the maximum infusion rate not exceeding 5 ml/min.
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and toxicity of Erbitux treatment
Frequency and severity of all AEs and serious adverse events; Laboratory information (haematology, clinical chemistry, EGFR test and KRAS test).
Measured: 120 minutes and for the subsequent weekly doses is 60 minutes. Before, during and at the end of Erbitux treatment period
Secondary outcomes (1)
Clinical efficacy of Erbitux treatment
The following data will be collected:
- Best tumor response with Erbitux treatment
- Time to progression of tumor with Erbitux treatment
- Duration of response with Erbitux treatment
Measured: 120 minutes and for the subsequent weekly doses is 60 minutes From the start of treatment with Erbitux until progressive disease, Erbitux related intolerable toxicities, death, or withdrawal of Erbitux treatment whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startSep 2008
- Primary completionDec 2011
- Study completionJan 2012
Why it stopped: This study was terminated due to low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Ltd.
- Responsible party
- Sponsor
- Investigators
- Tae-Won Kim, M.D., Ph.D., Principal investigator, Asan Medical Center, Seoul, Korea, Republic of
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074333
- Sponsor's protocol ID
- EMR 62202-507
- Status last verified
- Jun 2014
- First submitted
- 22 Feb 2010
- Last updated
- 17 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Observational Study on Erbitux® (Cetuximab) in Patients With EGFR-expressing, KRAS Wild-type Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01074333
- Acronym / sponsor ID
- EMR 62202-507
- Conditions
- Colorectal Neoplasm
- Keywords
- Colorectal cancer, Metastasis, Cetuximab, Erbitux, Epidermal growth factor receptor
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This study was terminated due to low recruitment
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Ltd.
- Study start
- Sep 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 24 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational, non-interventional, uncontrolled, multicentric safety study in subjects with epidermal growth factor receptor (EGFR)-expressing, V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) wild-type mCRC. The study aims to collect safety data related to Erbitux treatment from a total of at least 400 mCRC subjects from about 35 institutions from the start of treatment with Erbitux until progressive disease, Erbitux-related intolerable toxicities, death, or withdrawal of Erbitux treatment (whichever occurs first).
Detailed description
Colorectal cancer is the fourth commonest form of cancer worldwide and remains a leading malignancy both in incidence and mortality. Erbitux is an immunoglobulin G1 monoclonal antibody that specifically blocks ligand binding to the EGFR with high affinity, thereby preventing downstream signal transduction and cellular responses. Erbitux enhances the effects of some common chemotherapy agents and radiotherapy and demonstrates minimal overlapping toxicities with these approaches. Erbitux in combination with other treatment modalities, has also shown efficacy in the treatment of a number of solid tumors, including mCRC, squamous cell carcinoma of the head and neck, and non-small cell lung cancer. Based on several studies conducted in the past, Erbitux has been approved for the treatment of subjects with EGFR-expressing, KRAS wild-type mCRC, as a single agent in subjects who have failed oxaliplatin-and irinotecan-based therapy and who are intolerant to irinotecan or in combination with chemotherapy. The most common Erbitux-related adverse events (AEs) are related to skin, infusion, and hypersensitivity reactions. Other side effects with Erbitux monotherapy include asthenia, dyspnoea, mucositis, nausea, pain, fever and headache.
OBJECTIVES
Primary objective:
- To obtain safety information on the use of Erbitux in subjects with EGFR-expressing, KRAS wild-type mCRC in terms of frequency and severity of AEs
Secondary objective:
- To gather clinical efficacy information of the treatment
The study will primarily collect safety data related to Erbitux treatment along with the clinical efficacy information from the start of treatment with Erbitux until progressive disease, Erbitux related intolerable toxicities, death, or withdrawal of Erbitux treatment whichever occurs first. All subjects will be enrolled in the order to visit the physician after making contract and each subject will be observed for a period of 4 months in average. Erbitux will be prescribed to mCRC subjects according to the approved national label as in routine clinical practice under the supervision of an investigator experienced in the use of antineoplastic medicinal products. Prior to the first infusion, subjects will receive pre-medication with an antihistamine and a corticosteroid. The initial dose of Erbitux is 400 mg/m2 body surface area and the subsequent weekly doses are 250 mg/m2 each administered intravenously (i.v.) via in-line filtration with an infusion pump, gravity drip, or a syringe pump. The recommended infusion period for the initial dose is 120 minutes and for the subsequent weekly doses is 60 minutes with the maximum infusion rate not exceeding 5 ml/min. The observational period of this study is defined as from the first infusion of Erbitux until 28 days after the last infusion of Erbitux in each subject, regardless the reason of discontinuation of Erbitux treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with EGFR-expressing, KRAS wild-type mCRC undergoing treatment with Erbitux in Korea.
Key inclusion criteria (3 listed)
- Subjects who are eligible for Erbitux treatment according to the indication in the national label of Erbitux (i.e. in EGFR expressing, KRAS wild-type metastatic colorectal adenocarcinoma).
- Subjects who have failed oxaliplatin and irinotecan-based therapy and who are intolerant to irinotecan in mCRC.
- Subjects who have signed the informed consent form
Key exclusion criteria (1 listed)
- Subjects who do not fall under the approved indications according to the national label of Erbitux.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CetuximabAlso: ErbituxIn subjects with mCRC, cetuximab will be used in combination with chemotherapy or as a single agent according to the approved national label as in routine clinical practice. The initial dose of Erbitux is 400 mg/m2 body surface area and the subsequent weekly doses are 250 mg/m2 each administered i.v. via in-line filtration with an infusion pump, gravity drip, or a syringe pump. The recommended infusion period for the initial dose is 120 minutes and for the subsequent weekly doses is 60 minutes with the maximum infusion rate not exceeding 5 ml/min. | Drug | – |
Primary outcome
Safety and toxicity of Erbitux treatment
Time frame: 120 minutes and for the subsequent weekly doses is 60 minutes. Before, during and at the end of Erbitux treatment period
Frequency and severity of all AEs and serious adverse events; Laboratory information (haematology, clinical chemistry, EGFR test and KRAS test).
1 secondary outcome
Clinical efficacy of Erbitux treatment
Time frame: 120 minutes and for the subsequent weekly doses is 60 minutes From the start of treatment with Erbitux until progressive disease, Erbitux related intolerable toxicities, death, or withdrawal of Erbitux treatment whichever occurs first
Results and safety
The study was stopped early (reason given: This study was terminated due to low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2014.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tae-Won Kim, M.D., Ph.D. principal investigator
Asan Medical Center, Seoul, Korea, Republic of
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasm, run by Merck KGaA, Darmstadt, Germany at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: This study was terminated due to low recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and toxicity of Erbitux treatment (time frame: 120 minutes and for the subsequent weekly doses is 60 minutes. Before, during and at the end of Erbitux treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2014.