Colorectal CancerPhase 2Everest2NCT01251536
Cetuximab Standard or Dose Escalation in First Line Colorectal Cancer
A Phase 2 study testing Dose escalation of cetuximab and Standard first line treatment with cetuximab + Folfiri in people with Colorectal Cancer, run by Universitaire Ziekenhuizen KU Leuven at 30 sites in 5 countries.
Trial summary
The purposes of this study are to determine whether administering escalating doses of cetuximab in patients with no early skin toxicity could delay the progression of disease in a significant proportion of patients and to study the molecular signatures of response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Dose escalation of cetuximab and Standard first line treatment with cetuximab + Folfiri
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 30 sitesin 5 countries
- Study dates
- Dec 2010to Jul 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent (+ optional for PK and TR) must be given according to ICH/GCP and national/local regulations.
- Patient is at least 18 years of age.
- Patient's body weight is ≤ 120 kg.
- Histologically proven and measurable (RECIST criteria v.1.1) metastatic adenocarcinoma of the colon or rectum, not in a previously irradiated area.
- K-Ras wild type tumour eligible for treatment with cetuximab.
- Unresectable metastatic disease.
Show all 16Show fewer
- Life expectancy of at least 12 weeks.
- WHO ECOG performance status: 0 or 1.
- Effective contraception for both male and female patients if the risk of conception exists.
- Adequate organ function.
- Adequate bone marrow, hepatic and renal function (assessed within 14 days prior to study entry):
- Hemoglobin > 10.0 g/dL, absolute neutrophil count > 1.5 x 109/L, platelet count > 100 x 109/L
- ALAT, ASAT < 2.5 x ULN, up to < 5 x ULN in case of liver metastases
- Alkaline phosphatase < 2.5 x ULN
- Total bilirubin < 1.5 x ULN
- Creatinine clearance > 50 mL/min (calculated according to Cockroft and Gault)
Who cannot join
- Prior treatment for metastatic disease (adjuvant therapy with fluoropyrimidines +/-oxaliplatin based regimens allowed if stopped 6 months prior to registration on study).
- Prior treatment with EGFR inhibitor or chemotherapy with irinotecan in adjuvant settings.
- Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study entry.
- Administration of any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment.
- Concurrent chronic systemic immune therapy, chemotherapy, radiation therapy or hormone therapy not indicated in the study protocol.
- Any active dermatological condition > grade 1.
Show all 17Show fewer
- Brain metastasis (known or suspected).
- Significant impairment of intestinal absorption (e.g. chronic diarrhea, inflammatory bowel disease).
- Other uncontrolled concomitant illness, including serious uncontrolled intercurrent infection.
- Uncontrolled coronary artery disease and/or unstable angina, a history of a myocardial infarction within the last 12 months or heart failure NYHA class III or IV. High risk of uncontrolled arrhythmia.
- Known allergy or any other adverse reaction to any of the drugs or to any related compound.
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- Gilbert disease.
- Previous (within 5 years) or concurrent malignancies at other sites with the exception of surgically cured or adequately treated carcinoma in-situ of the cervix and basal cell carcinoma of the skin.
- Organ allografts requiring immunosuppressive therapy.
- Pregnancy (absence confirmed by serum/urine beta human choriongonadotrophin in pre-menopausal women) or breast-feeding.
- Medical, social or psychological condition which, in the opinion of the investigator, would not permit the patient to complete the study or sign meaningful informed consent.
Trial locations and contacts
30 sites in 5 countries.
30 sites in 5 countries
Belgium12 sites
Imelda Ziekenhuis
Bonheiden
Erasme Hospital
Brussels, 1070
Cliniques Universitaires St Luc
Brussels, 1200
AZ Middelares Gent
Ghent
UZ Gent
Ghent
Centre Hospitalier de Jolimont-Lobbes, Oncology Médicale
Haine-Saint-Paul
AZ Groeninge
Kortrijk, 8500
UZ Gasthuisberg
Leuven, 3000
CHC Saint Joseph
Liège
AZ Sint Maarten Mechelen/Duffel
Mechelen
H. Hartziekenhuis
Roeselare, 8800
AZ Turnhout (Campus St Elisabeth)
Turnhout
Austria6 sites
Universitätsklinik für Innere medizin, Klinishe abteilung für hämatologie und Onkologie
Innsbruck
LKH Leoben, abteilung f. innere Medizin
Leoben
AKH Linz, Innere Medizin 3, Zentrum für Hämatologie und medizinishe Onkologie
Linz
Landeskrankenhaus Salzburg, Univ. Klinik für innere Medizin III, Universitätsklinikum der PMU
Salzburg
Krankenanstalt Rudolfstiftung, 1 medizinishe Abteilung
Vienna
St Vincent Krankenhaus Betriebs GmbH
Zams
France5 sites
Hôpital Avicennes
Bobigny
Hôpital Saint-André
Bordeaux, 33000
Hopital Européen Georges Pompidou
Paris, 75015
Centre Eugène Marquis
Rennes, 35042
CHU Charles Nicolle
Rouen, 76031
Spain5 sites
Hospital Universitari Vall d'Hebron
Barcelona, 8035
Institut Català d'Oncologia
Barcelona
Hospital Universitario Marqués de Valdecilla
Santander
Hospital Universitario Virgen del Rocío
Seville
Hospital Clinico Universitario De Valencia
Valencia
Hungary2 sites
State Health Center
Budapest, 1062
Medical Center of the University of Pecs , National Institute Oncology
Budapest, 1122
About this study
Official title: A Two Arm Phase II Study of FOLFIRI in Combination With Standard or Escalating Dose of Cetuximab as First Line Treatment of K-Ras Wild Type Metastatic Colorectal Cancer: Everest 2
The purposes of this study are to determine whether administering escalating doses of cetuximab in patients with no early skin toxicity could delay the progression of disease in a significant proportion of patients and to study the molecular signatures of response.
Read the detailed description
Colorectal carcinoma (CRC) is the third most common form of cancer worldwide and remains a leading malignancy both in incidence and mortality.
In the light of existing knowledge, the investigators propose a phase II open label, two arm study in patients presenting with K-Ras wild-type metastatic colorectal tumours in the first line setting. The standard combination of irinotecan plus infusional 5-FU/LV (FOLFIRI) and cetuximab will be given to all patients entering the study. As the investigators hypothesize that increasing the dose of cetuximab might increase the intensity of skin reactions that directly correlates with outcome, in patients experiencing no skin toxicity, the dose of cetuximab will be escalated from 250 mg/m2 to 350 mg/m2 and then up to 500 mg/m2, in order to better define the effect of dose escalation in the first-line setting in a K-Ras wild type tumour population and in an attempt to increase efficacy.
Pharmacokinetic studies will be performed to document PK parameters of cetuximab in patients from both arms in selected centers.
Translational research studies are planned for all patients. Some more in depth molecular testing will be performed in a subset of patients from whom three serial tissue samples from accessible metastases by biopsy are available.
- Conditions
- Colorectal Cancer
- Being tested
- Dose escalation of cetuximab, Standard first line treatment with cetuximab + Folfiri
- Keywords
- colorectal cancer, K-Ras wildtype, first line metastatic, standard cetuximab + FOLFIRI, dose escalation cetuximab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose escalation of cetuximabDrug
Also called Erbitux
Dose, frequency \& treatment mode: 400 mg/m2 (loading at day 1) followed by 250 mg/m2 weekly (at day 8 and 15)
Arm allocation at day 22:
Patients with skin toxicity grade 0 will follow an increasing dose schedule: on days 22 and 29 they will receive 350 mg/m2 and from day 36 onwards, 500 mg/m2 weekly
Standard first line treatment with cetuximab + FolfiriDrug
Also called Erbitux
Dose, frequency \& treatment mode: 400 mg/m2 (loading at day 1) followed by 250 mg/m2 weekly (at day 8 and 15)
Arm allocation at day 22:
Patients with skin toxicity grade 1-4 or other significant toxicity who are not eligible for dose escalation will continue on the standard dose of cetuximab: 250 mg/m2 weekly.
| Study group | Role | What they receive |
|---|---|---|
| Arm B - standard dose of cetuximab | Other | Patients with skin toxicity grade 1-4 or other significant toxicity who are not eligible for dose escalation will continue on the standard dose of cetuximab 250 mg/m2 weekly. No comparison between arms was planned. Receives: Drug: Standard first line treatment with cetuximab + Folfiri |
| Arm A - dose escalation of cetuximab | Experimental | Patients with skin toxicity grade 0 will follow an increasing dose schedule: on days 22 and 29 they will receive 350 mg/m2 and from day 36 onwards, 500 mg/m2 weekly. Receives: Drug: Dose escalation of cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS Probability Rate at 9 Months in the Dose Escalation Arm
A precise estimate (+/- 10%) of the probability of not having progression at 9 months. This measure is an estimation derived from the Kaplan-Meier algorithm and does not represent a dimple percentage of participants.
Measured: 9 months
Secondary outcomes (17)
Progression Free Survival (PFS) Median Time
Progression free survival time was considered from start of treatment until the first observation of disease progression or death from any cause, whichever occurred first. All patients (ITT).
Measured: Treatment + follow-up (3 years from database lock)
Progression Free Survival (PFS) Median Time for Resected Patients
Progression free survival time was considered from start of treatment until the first observation of disease progression or death from any cause, whichever occurred first. This is the subset of resected patients (resection of secondary lesions with curative intent was performed). Patients resected after they started subsequent anti-cancer treatment or after progression on treatment were not considered as 'resected for metastatic lesions on study'. Patients were not censored at time of surgery.
Measured: Treatment + follow-up (3 years from database lock)
Progression Free Survival (PFS) Time for Resected Versus Non-resected Patients (Hazard Ratio)
Progression free survival time was considered from start of treatment until the first observation of disease progression or death from any cause, whichever occurred first. This is the subset of resected patients (resection of secondary lesions with curative intent was performed). Patients resected after they started subsequent anti-cancer treatment or after progression on treatment were not considered as 'resected for metastatic lesions on study'. Patients were not censored at time of surgery.
Measured: Treatment + follow-up (3 years from database lock)
Death Rates by 3 Years Follow-up
Deaths by 3 years follow-up after last cetuximab administration + 30 days. All patients (ITT).
Measured: Treatment + follow-up (3 years from database lock)
Overall Survival (OS) Median Time
Overall survival was considered from start of treatment to death. All patients (ITT).
Measured: Treatment + follow-up (3 years from database lock)
Overall Survival (OS) Median Time for Resected Patients
Overall survival was considered from start of treatment to death. Subset of resected patients (resection of secondary lesions with curative intent was performed). Patients resected after they started subsequent anti-cancer treatment (600-01-006 and 600-04-006) or after progression (100-02-002,
End point description:
Clinical trial results 2009-009992-36 version 1 EU-CTR publication date: Page 15 of 38 200-03-001, and 600-01-038) were not considered as 'resected for metastatic lesions on study.
Measured: Treatment + follow-up (3 years from database lock)
Overall Response
Overall response is defined as the best tumor response on treatment of either complete response (CR) or partial response (PR) (CR + PR). Tumor response is based on the CT/MRI assessments of target and non-target lesions as well as considering the occurrence of new lesions as per RECIST criteria. All patients (ITT).
Measured: Treatment duration (interval from first infusion to last infusion on study for each patient), an average of 8.5 months.
Overall Response in Patients With Liver-limited Disease
Overall response is defined as the best tumor response on treatment of either complete response (CR) or partial response (PR) (CR + PR). Tumor response is based on the imaging (CT/MRI) assessments of target and non-target lesions as well as considering the occurrence of new lesions as per RECIST criteria. Subset of patients with liver-limited disease.
Measured: Treatment duration (interval from first infusion to last infusion on study for each patient), an average of 8.5 months.
Disease Control
Disease control is defined as a best response on treatment (e.g. till end of treatment evaluation) of either complete response (CR), partial response (PR), or stable disease (SD) (CR + PR + SD). RECIST criteria (CT/MRI). All patients (ITT).
Measured: Treatment duration (interval from first infusion to last infusion on study for each patient), an average of 8.5 months.
Disease Control in Patients With Liver-limited Disease
Disease control is defined as a best response on treatment (e.g. till end of treatment evaluation) of either complete response (CR), partial response (PR), or stable disease (SD) (CR + PR + SD). RECIST criteria (CT/MRI). Subset of patients with liver-limited disease.
Measured: Treatment duration (interval from first infusion to last infusion on study for each patient), an average of 8.5 months.
Duration of Response
The duration of response in responding patients is defined as the time interval from the time measurement criteria are first met for CR/PR during treatment to either the first time disease progression is documented or death. Subset of responders.
Measured: Treatment + follow-up (3 years from database lock)
Duration of Response in Liver-limited Disease Patients
The duration of response in responding patients is defined as the time interval from the time measurement criteria are first met for CR/PR during treatment to either the first time disease progression is documented or death. Subset of responders among patients with liver-limited disease.
Measured: Treatment + follow-up (3 years from database lock)
Resections for Metastatic Lesions
All patients were deemed non-resectable at baseline but some became resectable during or posttreatment.
All patients (ITT). Only those patients in whom resection of secondary lesions with curative intent was performed were considered as 'resected'. Patients resected after they started subsequent anti-cancer treatment (600-01-006 and 600-04-006) or after progression (100-02-002, 200-03-001, and 600-01-038) were not considered as 'resected for metastatic lesions on study'.
Measured: Treatment + follow-up (3 years from database lock)
R0 Rate (Free of Tumor After Resection for Metastatic Lesions)
Rate of patients free of tumor after surgery. Subset of resected patients (resection of secondary lesions with curative intent was performed). Patients resected after they started subsequent anti-cancer treatment (600-01-006 and 600-04-006) or after progression (100-02-002, 200-03-001, and 600-01- 038) were not considered as 'resected for metastatic lesions on study'.
Measured: Treatment + follow-up (3 years from database lock)
Skin Toxicity (Safety)
Treatment-emergent adverse events identified by the investigator as skin reaction or events with description skin infection or nail infection. Grading of severity was per NCI CTCAE version 4.0. All events are summarized based on the timing of occurrence per Arm in the first two rows, and worst grade per patient events are presented (following 3 rows). Grade 0 is the absence of any skin reaction and grade 3 is worst severity. All patients treated (Safety set).
Note: There were 3 deviations from arm allocation rules based on the occurrence of skin toxicity. Detailed data is available upon request.
Measured: From signature of informed consent to last cetuximab administration on study plus 30 days for each patient, an average of 9.5 months.
Laboratory Safety Assessments
Severe laboratory abnormalities (hematology and biochemistry grade 3 and higher). Worst grade per patient. All patients treated (Safety set).
Measured: From signature of informed consent to last cetuximab administration on study plus 30 days for each patient, an average of 9.5 months.
Deaths Till 30 Days From Last Cetuximab Administration
Deaths of all causes occuring between the signature of consent and the date of last cetuximab administration + 30 days are listed per arm. None of these fatalities were deemed related to the investigational drug.
Measured: From signature of informed consent to last cetuximab administration on study plus 30 days for each patient, an average of 9.5 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionJun 2016
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Eric Van Cutsem, MD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251536
- Sponsor's protocol ID
- S51532
- Other IDs
- 2009-009992-36, 2009
- Acronym
- Everest2
- Status last verified
- Oct 2019
- First submitted
- 1 Dec 2010
- Last updated
- 11 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Arm Phase II Study of FOLFIRI in Combination With Standard or Escalating Dose of Cetuximab as First Line Treatment of K-Ras Wild Type Metastatic Colorectal Cancer: Everest 2
- ClinicalTrials.gov ID
- NCT01251536
- Acronym / sponsor ID
- Everest2 / S51532
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, K-Ras wildtype, first line metastatic, standard cetuximab + FOLFIRI, dose escalation cetuximab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- Dec 2010 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 2 Dec 2010 (estimated)
- Results
- Posted 11 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposes of this study are to determine whether administering escalating doses of cetuximab in patients with no early skin toxicity could delay the progression of disease in a significant proportion of patients and to study the molecular signatures of response.
Detailed description
Colorectal carcinoma (CRC) is the third most common form of cancer worldwide and remains a leading malignancy both in incidence and mortality.
In the light of existing knowledge, the investigators propose a phase II open label, two arm study in patients presenting with K-Ras wild-type metastatic colorectal tumours in the first line setting. The standard combination of irinotecan plus infusional 5-FU/LV (FOLFIRI) and cetuximab will be given to all patients entering the study. As the investigators hypothesize that increasing the dose of cetuximab might increase the intensity of skin reactions that directly correlates with outcome, in patients experiencing no skin toxicity, the dose of cetuximab will be escalated from 250 mg/m2 to 350 mg/m2 and then up to 500 mg/m2, in order to better define the effect of dose escalation in the first-line setting in a K-Ras wild type tumour population and in an attempt to increase efficacy.
Pharmacokinetic studies will be performed to document PK parameters of cetuximab in patients from both arms in selected centers.
Translational research studies are planned for all patients. Some more in depth molecular testing will be performed in a subset of patients from whom three serial tissue samples from accessible metastases by biopsy are available.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm B - standard dose of cetuximab | Other | Drug: Standard first line treatment with cetuximab + FolfiriPatients with skin toxicity grade 1-4 or other significant toxicity who are not eligible for dose escalation will continue on the standard dose of cetuximab 250 mg/m2 weekly. No comparison between arms was planned. |
| Arm A - dose escalation of cetuximab | Experimental | Drug: Dose escalation of cetuximabPatients with skin toxicity grade 0 will follow an increasing dose schedule: on days 22 and 29 they will receive 350 mg/m2 and from day 36 onwards, 500 mg/m2 weekly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Written informed consent (+ optional for PK and TR) must be given according to ICH/GCP and national/local regulations.
- Patient is at least 18 years of age.
- Patient's body weight is ≤ 120 kg.
- Histologically proven and measurable (RECIST criteria v.1.1) metastatic adenocarcinoma of the colon or rectum, not in a previously irradiated area.
- K-Ras wild type tumour eligible for treatment with cetuximab.
Key exclusion criteria (17 listed)
- Prior treatment for metastatic disease (adjuvant therapy with fluoropyrimidines +/-oxaliplatin based regimens allowed if stopped 6 months prior to registration on study).
- Prior treatment with EGFR inhibitor or chemotherapy with irinotecan in adjuvant settings.
- Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study entry.
- Administration of any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment.
- Concurrent chronic systemic immune therapy, chemotherapy, radiation therapy or hormone therapy not indicated in the study protocol.
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 |
|---|---|---|
| Dose escalation of cetuximabAlso: ErbituxDose, frequency \& treatment mode: 400 mg/m2 (loading at day 1) followed by 250 mg/m2 weekly (at day 8 and 15) Arm allocation at day 22: Patients with skin toxicity grade 0 will follow an increasing dose schedule: on days 22 and 29 they will receive 350 mg/m2 and from day 36 onwards, 500 mg/m2 weekly | Drug | Arm A - dose escalation of cetuximab |
| Standard first line treatment with cetuximab + FolfiriAlso: ErbituxDose, frequency \& treatment mode: 400 mg/m2 (loading at day 1) followed by 250 mg/m2 weekly (at day 8 and 15) Arm allocation at day 22: Patients with skin toxicity grade 1-4 or other significant toxicity who are not eligible for dose escalation will continue on the standard dose of cetuximab: 250 mg/m2 weekly. | Drug | Arm B - standard dose of cetuximab |
Primary outcome
PFS Probability Rate at 9 Months in the Dose Escalation Arm
Time frame: 9 months
A precise estimate (+/- 10%) of the probability of not having progression at 9 months. This measure is an estimation derived from the Kaplan-Meier algorithm and does not represent a dimple percentage of participants.
17 secondary outcomes
Progression Free Survival (PFS) Median Time
Time frame: Treatment + follow-up (3 years from database lock)
Progression Free Survival (PFS) Median Time for Resected Patients
Time frame: Treatment + follow-up (3 years from database lock)
Progression Free Survival (PFS) Time for Resected Versus Non-resected Patients (Hazard Ratio)
Time frame: Treatment + follow-up (3 years from database lock)
Death Rates by 3 Years Follow-up
Time frame: Treatment + follow-up (3 years from database lock)
Overall Survival (OS) Median Time
Time frame: Treatment + follow-up (3 years from database lock)
Overall Survival (OS) Median Time for Resected Patients
Time frame: Treatment + follow-up (3 years from database lock)
Overall Response
Time frame: Treatment duration (interval from first infusion to last infusion on study for each patient), an average of 8.5 months.
Overall Response in Patients With Liver-limited Disease
Time frame: Treatment duration (interval from first infusion to last infusion on study for each patient), an average of 8.5 months.
Disease Control
Time frame: Treatment duration (interval from first infusion to last infusion on study for each patient), an average of 8.5 months.
Disease Control in Patients With Liver-limited Disease
Time frame: Treatment duration (interval from first infusion to last infusion on study for each patient), an average of 8.5 months.
Duration of Response
Time frame: Treatment + follow-up (3 years from database lock)
Duration of Response in Liver-limited Disease Patients
Time frame: Treatment + follow-up (3 years from database lock)
Resections for Metastatic Lesions
Time frame: Treatment + follow-up (3 years from database lock)
R0 Rate (Free of Tumor After Resection for Metastatic Lesions)
Time frame: Treatment + follow-up (3 years from database lock)
Skin Toxicity (Safety)
Time frame: From signature of informed consent to last cetuximab administration on study plus 30 days for each patient, an average of 9.5 months.
Laboratory Safety Assessments
Time frame: From signature of informed consent to last cetuximab administration on study plus 30 days for each patient, an average of 9.5 months.
Deaths Till 30 Days From Last Cetuximab Administration
Time frame: From signature of informed consent to last cetuximab administration on study plus 30 days for each patient, an average of 9.5 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Eric Van Cutsem, MD principal investigator
UZ Leuven
30 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dose escalation of cetuximab and Standard first line treatment with cetuximab + Folfiri in people with Colorectal Cancer, run by Universitaire Ziekenhuizen KU Leuven at 30 sites in 5 countries.
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 16 inclusion and 17 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: finished, as of the sponsor's last update on 11 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Belgium, Austria, France, Spain, Hungary. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
PFS Probability Rate at 9 Months in the Dose Escalation Arm (time frame: 9 months). 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 11 Oct 2019.