Cancer ColorectalPhase 2CETIDYLNCT04189055
Cetuximab as Salvage Therapy in Patients With Neo Wild-type RAS/RAF Metastatic Colorectal Cancer With Liver Metastases.
A Phase 2 study testing Cetuximab and Irinotecan in people with Cancer Colorectal, run by Hôpital Franco-Britannique-Fondation Cognacq-Jay at 1 site in France.
Trial summary
The purpose of this study is to investigate the efficacy of cetuximab or cetuximab-irinotecan in patients with neo wild-type colorectal cancer who have been previously treated for metastatic disease. Patients will be included in cohort #1 or cohort #2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Colorectal
- What is being tested?
- Cetuximab and Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jan 2020to Jul 2024
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent and stated willingness to comply with all study procedures and availability for the duration of the study,
- Male or female subjects, ≥18 years of age,
- ECOG performance status (ECOG PS, Appendix 15.1) ≤2,
- Unresectable metastatic RAS mutant (either KRAS or NRAS tumor gene mutation) colorectal cancer,
- At least one (≥1) measurable and/or evaluable liver metastasis,
- Prior therapy (resistant or intolerant) with fluoropyrimidines, oxaliplatin, irinotecan and antiangiogenic agent (ie, bevacizumab and/or aflibercept),
Show all 11Show fewer
- Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:
- Hematological status: neutrophils (ANC) ≥1.5x109/L; platelets ≥100x109/L; haemoglobin ≥9g/dL Adequate renal function: serum creatinine clearance (MDRD) ≥ 50 mL/min/1,73 m2 Adequate liver function: serum bilirubin ≤1.5x upper normal limit (ULN), alkaline phosphatase <5xULN, AST and ALT ≤5xULN, Adequate serum electrolyte levels (magnesium, potassium, calcium) prior to initiation of study treatment,
- Negative pregnancy test within 7 days prior to initiation of the study drug for female patients of childbearing potential,
- Effective contraception for both male and female subjects if the risk of conception exists
- Registration in a national health care system.
Who cannot join
- Known allergy or hypersensitivity reactions to any study drug,
- Women who are pregnant or breastfeeding,
- Inability to comply with study and follow-up procedures as judged by the Investigator,
- Patient with BRAF mutant colorectal cancer
- History of interstitial lung disease
- Treatment with strong CYP3A4-enzyme inducers such as anticonvulsants (phenytoin, phenobarbital or carbamazepine), rifampin, rifabutin and St. John's wort for patients of cohort #2
Show all 12Show fewer
- Treatment with strong CYP3A4-enzyme inhibitors (e.g. grapefruit juice, clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) for patients of cohort #2
- Treatment with strong UGT1A inhibitors (e.g. atazanavir, gemfibrozil, indinavir) for patients of cohort # 2
- Patients of cohort #2 with known UGT1A deficiency
- Uncontrolled illness, including but not limited to ongoing bacterial, viral or fungal infection requiring systemic therapy, metabolic dysfunction, physical examination/ clinical laboratory finding that leads to a reasonable suspicion of a disease/condition that contraindicates the use of any of investigational drugs that may affect the interpretation of the results, or that may render the subject at high risk of treatment complications.
- Patient with current intestinal obstruction or history of chronic inflammatory bowel disease
- Subjects under guardianship, curatorship or judicial protection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Franco-British Hospital - GCS IHFB Cognacq-Jay
Levallois-Perret, 92300
About this study
Official title: Cetuximab as Salvage Therapy in Patients With Neo Wild-type RAS/RAF Metastatic Colorectal Cancer With Liver Metastases. A Proof-of-concept Study
The purpose of this study is to investigate the efficacy of cetuximab or cetuximab-irinotecan in patients with neo wild-type colorectal cancer who have been previously treated for metastatic disease.
Patients will be included in cohort #1 or cohort #2. The inclusion in cohort #2 will start when the results of the cohort #1 are available.
Patient will receive either cetuximab alone (cohort #1) or cetuximab with irinotecan (cohort #2).
Read the detailed description
Background - Rationale
KRAS and NRAS mutations are present in roughly 50% of patients with advanced colorectal cancer and predict failure of anti-EGFR mabs therapies, thus genotyping colorectal cancer (CRC) is mandatory for personalized treatments.
Research has been selectively concentrated on the emergence of resistant clones in the blood of patients with wild-type (WT) RAS CRC as biomarker of anti-EGFR therapy resistance.
It has been suggested that patients with metastatic CRC harboring mutated primary tumors, thus not candidate to EGFR inhibitors, frequently have WT RAS circulating tumor cells in blood. Preliminary data suggest that patients with mutant KRAS colon cancer can frequently (50%) switch to a prevalent WT KRAS disease in course of treatment with anti-angiogenic drugs.
In patients with RAS wild-type colorectal cancer who previously received standard therapies, anti-EGFR mabs achieve a response rate of 20% as monotherapy and 30-40% in combination with irinotecan.
The aim of this study is to evaluate the efficacy of cetuximab in patients with pretreated neo wild-type colorectal cancer using liquid biopsies for RAS molecular assessment
Study Objectives
Primary:
- To evaluate the response rate using RECIST 1.1
Secondary:
- To evaluate progression-free survival (PFS), overall survival (OS)
- To evaluate disease control rate (DCR)
- To evaluate safety
Exploratory:
- Frequency of neo wild-type tumors
- Frequency of RAS and BRAF neomutations during treatment
Study Design Prospective multicentric single-arm open-label phase II study in to 2 successive patient cohorts (cohort #1 followed by cohort #2).
Molecular screening using Idylla™ (Biocartis) ctKRAS and ctNRAS/BRAF Mutation Assays.
Cohort #1: Patients will be treated with cetuximab monotherapy (cetuximab 500mg/m² IV, day 1).
Cohort #2: Patients will be treated with cetuximab and irinotecan (cetuximab 500mg/m² IV, day 1; irinotecan 180mg/m² IV, day 1).
In both cohorts, treatment will be given intravenously every 14 days (q2w) until disease progression or limiting toxicity. Tumor evaluations will be done with CT-scan (or MRI) every 8 weeks using RECIST v1.1.
- Conditions
- Cancer Colorectal
- Being tested
- Cetuximab, Irinotecan
- Keywords
- Liver metastasis, KRAS, NRAS
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Also called Erbitux
Cetuximab 500mg/m² IV, day 1
IrinotecanDrug
Also called Campto
Irinotecan 180mg/m² IV, day 1
| Study group | Role | What they receive |
|---|---|---|
| Cohort #1 | Experimental | Cetuximab monotherapy (500mg/m² IV, day 1) Receives: Drug: Cetuximab |
| Cohort #2 | Experimental | Cetuximab and irinotecan (cetuximab 500mg/m² IV, day 1; irinotecan 180mg/m² IV, day 1). Receives: Drug: Cetuximab; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
Tumor measurements will be obtained at baseline and every 8 weeks following treatment initiation. At the investigator's discretion, tumor assessments may be repeated at any time if progressive disease is suspected. Tumor response and progression will be assessed by the Investigator using RECIST v1.1.
Measured: 4 months
Secondary outcomes (4)
Overall survival
OS is defined as the time interval from the date of inclusion to the date of death from any cause. Alive patients will be censored at the last date known to be alive, either during study treatment period or during follow-up period.
Measured: time interval from inclusion to the date of death from any cause. Assessed up to 12 months after the beginning of the study
Progression-free survival
PFS is defined as the time interval from the date of inclusion to the date of first documented disease progression or death from any cause, whichever occurs first. Alive patients without progression will be censored at the last tumor assessment, either during study treatment period or during follow-up period.
Measured: the time interval from inclusion to the date of first documented disease progression or death from any cause, whichever occurs first. Assessed up to 12 months after the beginning of the study
Disease Control rate
Disease control rate (DCR) is defined as the percentage of patients achieving CR, PR, or stable disease (SD).
Measured: from baseline until end of treatment, assessed up to 12 months after the beginning of the study
Tolerance
Frequency of adverse events using NCI-CTCAE v5.0
Measured: Assessed from study entry to 1 month after last study drug administration, assessed up to 12 months after the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start7 Jan 2020
- Primary completionApr 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cancer ColorectalStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Franco-Britannique-Fondation Cognacq-Jay
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoist CHIBAUDEL, MD, Principal investigator, Franco-British Hospital - GCS IHFB Cognacq-Jay
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189055
- Sponsor's protocol ID
- FBH-001
- Acronym
- CETIDYL
- Status last verified
- Jun 2023
- First submitted
- 27 Nov 2019
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amado RG, Wolf M, Peeters M, Van Cutsem E, Siena S, Freeman DJ, Juan T, Sikorski R, Suggs S, Radinsky R, Patterson SD, Chang DD. Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J Clin Oncol. 2008 Apr 1;26(10):1626-34. doi: 10.1200/JCO.2007.14.7116. Epub 2008 Mar 3.
PubMed 18316791Andre T, Blons H, Mabro M, Chibaudel B, Bachet JB, Tournigand C, Bennamoun M, Artru P, Nguyen S, Ebenezer C, Aissat N, Cayre A, Penault-Llorca F, Laurent-Puig P, de Gramont A; GERCOR. Panitumumab combined with irinotecan for patients with KRAS wild-type metastatic colorectal cancer refractory to standard chemotherapy: a GERCOR efficacy, tolerance, and translational molecular study. Ann Oncol. 2013 Feb;24(2):412-419. doi: 10.1093/annonc/mds465. Epub 2012 Oct 5.
PubMed 23041588Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593Cunningham D, Humblet Y, Siena S, Khayat D, Bleiberg H, Santoro A, Bets D, Mueser M, Harstrick A, Verslype C, Chau I, Van Cutsem E. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med. 2004 Jul 22;351(4):337-45. doi: 10.1056/NEJMoa033025.
PubMed 15269313Elez E, Kocakova I, Hohler T, Martens UM, Bokemeyer C, Van Cutsem E, Melichar B, Smakal M, Csoszi T, Topuzov E, Orlova R, Tjulandin S, Rivera F, Straub J, Bruns R, Quaratino S, Tabernero J. Abituzumab combined with cetuximab plus irinotecan versus cetuximab plus irinotecan alone for patients with KRAS wild-type metastatic colorectal cancer: the randomised phase I/II POSEIDON trial. Ann Oncol. 2015 Jan;26(1):132-140. doi: 10.1093/annonc/mdu474. Epub 2014 Oct 15.
PubMed 25319061Hecht JR, Patnaik A, Berlin J, Venook A, Malik I, Tchekmedyian S, Navale L, Amado RG, Meropol NJ. Panitumumab monotherapy in patients with previously treated metastatic colorectal cancer. Cancer. 2007 Sep 1;110(5):980-8. doi: 10.1002/cncr.22915.
PubMed 17671985Jonker DJ, O'Callaghan CJ, Karapetis CS, Zalcberg JR, Tu D, Au HJ, Berry SR, Krahn M, Price T, Simes RJ, Tebbutt NC, van Hazel G, Wierzbicki R, Langer C, Moore MJ. Cetuximab for the treatment of colorectal cancer. N Engl J Med. 2007 Nov 15;357(20):2040-8. doi: 10.1056/NEJMoa071834.
PubMed 18003960Karapetis CS, Khambata-Ford S, Jonker DJ, O'Callaghan CJ, Tu D, Tebbutt NC, Simes RJ, Chalchal H, Shapiro JD, Robitaille S, Price TJ, Shepherd L, Au HJ, Langer C, Moore MJ, Zalcberg JR. K-ras mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med. 2008 Oct 23;359(17):1757-65. doi: 10.1056/NEJMoa0804385.
PubMed 18946061Pfeiffer P, Nielsen D, Bjerregaard J, Qvortrup C, Yilmaz M, Jensen B. Biweekly cetuximab and irinotecan as third-line therapy in patients with advanced colorectal cancer after failure to irinotecan, oxaliplatin and 5-fluorouracil. Ann Oncol. 2008 Jun;19(6):1141-5. doi: 10.1093/annonc/mdn020. Epub 2008 Feb 14.
PubMed 18281264
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cetuximab as Salvage Therapy in Patients With Neo Wild-type RAS/RAF Metastatic Colorectal Cancer With Liver Metastases. A Proof-of-concept Study
- ClinicalTrials.gov ID
- NCT04189055
- Acronym / sponsor ID
- CETIDYL / FBH-001
- Conditions
- Cancer Colorectal
- Keywords
- Liver metastasis, KRAS, NRAS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Hôpital Franco-Britannique-Fondation Cognacq-JayUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 6 Dec 2019 (actual)
- 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.
The purpose of this study is to investigate the efficacy of cetuximab or cetuximab-irinotecan in patients with neo wild-type colorectal cancer who have been previously treated for metastatic disease.
Patients will be included in cohort #1 or cohort #2. The inclusion in cohort #2 will start when the results of the cohort #1 are available.
Patient will receive either cetuximab alone (cohort #1) or cetuximab with irinotecan (cohort #2).
Detailed description
Background - Rationale
KRAS and NRAS mutations are present in roughly 50% of patients with advanced colorectal cancer and predict failure of anti-EGFR mabs therapies, thus genotyping colorectal cancer (CRC) is mandatory for personalized treatments.
Research has been selectively concentrated on the emergence of resistant clones in the blood of patients with wild-type (WT) RAS CRC as biomarker of anti-EGFR therapy resistance.
It has been suggested that patients with metastatic CRC harboring mutated primary tumors, thus not candidate to EGFR inhibitors, frequently have WT RAS circulating tumor cells in blood. Preliminary data suggest that patients with mutant KRAS colon cancer can frequently (50%) switch to a prevalent WT KRAS disease in course of treatment with anti-angiogenic drugs.
In patients with RAS wild-type colorectal cancer who previously received standard therapies, anti-EGFR mabs achieve a response rate of 20% as monotherapy and 30-40% in combination with irinotecan.
The aim of this study is to evaluate the efficacy of cetuximab in patients with pretreated neo wild-type colorectal cancer using liquid biopsies for RAS molecular assessment
Study Objectives
Primary:
- To evaluate the response rate using RECIST 1.1
Secondary:
- To evaluate progression-free survival (PFS), overall survival (OS)
- To evaluate disease control rate (DCR)
- To evaluate safety
Exploratory:
- Frequency of neo wild-type tumors
- Frequency of RAS and BRAF neomutations during treatment
Study Design Prospective multicentric single-arm open-label phase II study in to 2 successive patient cohorts (cohort #1 followed by cohort #2).
Molecular screening using Idylla™ (Biocartis) ctKRAS and ctNRAS/BRAF Mutation Assays.
Cohort #1: Patients will be treated with cetuximab monotherapy (cetuximab 500mg/m² IV, day 1).
Cohort #2: Patients will be treated with cetuximab and irinotecan (cetuximab 500mg/m² IV, day 1; irinotecan 180mg/m² IV, day 1).
In both cohorts, treatment will be given intravenously every 14 days (q2w) until disease progression or limiting toxicity. Tumor evaluations will be done with CT-scan (or MRI) every 8 weeks using RECIST v1.1.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort #1 | Experimental | Drug: CetuximabCetuximab monotherapy (500mg/m² IV, day 1) |
| Cohort #2 | Experimental | Drug: Cetuximab, Drug: IrinotecanCetuximab and irinotecan (cetuximab 500mg/m² IV, day 1; irinotecan 180mg/m² IV, day 1). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provision of signed and dated informed consent and stated willingness to comply with all study procedures and availability for the duration of the study,
- Male or female subjects, ≥18 years of age,
- ECOG performance status (ECOG PS, Appendix 15.1) ≤2,
- Unresectable metastatic RAS mutant (either KRAS or NRAS tumor gene mutation) colorectal cancer,
- At least one (≥1) measurable and/or evaluable liver metastasis,
Key exclusion criteria (12 listed)
- Known allergy or hypersensitivity reactions to any study drug,
- Women who are pregnant or breastfeeding,
- Inability to comply with study and follow-up procedures as judged by the Investigator,
- Patient with BRAF mutant colorectal cancer
- History of interstitial lung disease
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: ErbituxCetuximab 500mg/m² IV, day 1 | Drug | Cohort #1, Cohort #2 |
| IrinotecanAlso: CamptoIrinotecan 180mg/m² IV, day 1 | Drug | Cohort #2 |
Primary outcome
response rate
Time frame: 4 months
Tumor measurements will be obtained at baseline and every 8 weeks following treatment initiation. At the investigator's discretion, tumor assessments may be repeated at any time if progressive disease is suspected. Tumor response and progression will be assessed by the Investigator using RECIST v1.1.
4 secondary outcomes
Overall survival
Time frame: time interval from inclusion to the date of death from any cause. Assessed up to 12 months after the beginning of the study
Progression-free survival
Time frame: the time interval from inclusion to the date of first documented disease progression or death from any cause, whichever occurs first. Assessed up to 12 months after the beginning of the study
Disease Control rate
Time frame: from baseline until end of treatment, assessed up to 12 months after the beginning of the study
Tolerance
Time frame: Assessed from study entry to 1 month after last study drug administration, assessed up to 12 months after the beginning of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Background: PubMed 18316791Amado RG, Wolf M, Peeters M, Van Cutsem E, Siena S, Freeman DJ, Juan T, Sikorski R, Suggs S, Radinsky R, Patterson SD, Chang DD. Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J Clin Oncol. 2008 Apr 1;26(10):1626-34. doi: 10.1200/JCO.2007.14.7116. Epub 2008 Mar 3.
- Background: PubMed 23041588Andre T, Blons H, Mabro M, Chibaudel B, Bachet JB, Tournigand C, Bennamoun M, Artru P, Nguyen S, Ebenezer C, Aissat N, Cayre A, Penault-Llorca F, Laurent-Puig P, de Gramont A; GERCOR. Panitumumab combined with irinotecan for patients with KRAS wild-type metastatic colorectal cancer refractory to standard chemotherapy: a GERCOR efficacy, tolerance, and translational molecular study. Ann Oncol. 2013 Feb;24(2):412-419. doi: 10.1093/annonc/mds465. Epub 2012 Oct 5.
- Background: PubMed 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Background: PubMed 15269313Cunningham D, Humblet Y, Siena S, Khayat D, Bleiberg H, Santoro A, Bets D, Mueser M, Harstrick A, Verslype C, Chau I, Van Cutsem E. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med. 2004 Jul 22;351(4):337-45. doi: 10.1056/NEJMoa033025.
- Background: PubMed 25319061Elez E, Kocakova I, Hohler T, Martens UM, Bokemeyer C, Van Cutsem E, Melichar B, Smakal M, Csoszi T, Topuzov E, Orlova R, Tjulandin S, Rivera F, Straub J, Bruns R, Quaratino S, Tabernero J. Abituzumab combined with cetuximab plus irinotecan versus cetuximab plus irinotecan alone for patients with KRAS wild-type metastatic colorectal cancer: the randomised phase I/II POSEIDON trial. Ann Oncol. 2015 Jan;26(1):132-140. doi: 10.1093/annonc/mdu474. Epub 2014 Oct 15.
- Background: PubMed 17671985Hecht JR, Patnaik A, Berlin J, Venook A, Malik I, Tchekmedyian S, Navale L, Amado RG, Meropol NJ. Panitumumab monotherapy in patients with previously treated metastatic colorectal cancer. Cancer. 2007 Sep 1;110(5):980-8. doi: 10.1002/cncr.22915.
- Background: PubMed 18003960Jonker DJ, O'Callaghan CJ, Karapetis CS, Zalcberg JR, Tu D, Au HJ, Berry SR, Krahn M, Price T, Simes RJ, Tebbutt NC, van Hazel G, Wierzbicki R, Langer C, Moore MJ. Cetuximab for the treatment of colorectal cancer. N Engl J Med. 2007 Nov 15;357(20):2040-8. doi: 10.1056/NEJMoa071834.
- Background: PubMed 18946061Karapetis CS, Khambata-Ford S, Jonker DJ, O'Callaghan CJ, Tu D, Tebbutt NC, Simes RJ, Chalchal H, Shapiro JD, Robitaille S, Price TJ, Shepherd L, Au HJ, Langer C, Moore MJ, Zalcberg JR. K-ras mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med. 2008 Oct 23;359(17):1757-65. doi: 10.1056/NEJMoa0804385.
- Background: PubMed 18281264Pfeiffer P, Nielsen D, Bjerregaard J, Qvortrup C, Yilmaz M, Jensen B. Biweekly cetuximab and irinotecan as third-line therapy in patients with advanced colorectal cancer after failure to irinotecan, oxaliplatin and 5-fluorouracil. Ann Oncol. 2008 Jun;19(6):1141-5. doi: 10.1093/annonc/mdn020. Epub 2008 Feb 14.
- 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.
Benoist CHIBAUDEL, MD principal investigator
Franco-British Hospital - GCS IHFB Cognacq-Jay
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab and Irinotecan in people with Cancer Colorectal, run by Hôpital Franco-Britannique-Fondation Cognacq-Jay at 1 site in France.
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 11 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 12 Jun 2023. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benoist CHIBAUDEL, MD (0147595965 ext. 33, benoist.chibaudel@ihfb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04189055, which also lists 9 linked publications.
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 12 Jun 2023.