Informations générales (source: ClinicalTrials.gov)
Cetuximab as Salvage Therapy in Patients With Neo Wild-type RAS/RAF Metastatic Colorectal Cancer With Liver Metastases. A Proof-of-concept Study (CETIDYL)
Interventional
Phase 2
Hôpital Franco-Britannique-Fondation Cognacq-Jay (Voir sur ClinicalTrials)
janvier 2020
juillet 2024
07 juin 2025
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).
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Franco-British Hospital - GCS IHFB Cognacq-Jay - 92300 - Levallois-Perret - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Provision of signed and dated informed consent and stated willingness to comply with
all study procedures and availability for the duration of the study,
2. Male or female subjects, ≥18 years of age,
3. ECOG performance status (ECOG PS, Appendix 15.1) ≤2,
4. Unresectable metastatic RAS mutant (either KRAS or NRAS tumor gene mutation)
colorectal cancer,
5. At least one (≥1) measurable and/or evaluable liver metastasis,
6. Prior therapy (resistant or intolerant) with fluoropyrimidines, oxaliplatin,
irinotecan and antiangiogenic agent (ie, bevacizumab and/or aflibercept),
7. 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,
8. Negative pregnancy test within 7 days prior to initiation of the study drug for
female patients of childbearing potential,
9. Effective contraception for both male and female subjects if the risk of conception
exists
10. Registration in a national health care system.
1. Provision of signed and dated informed consent and stated willingness to comply with
all study procedures and availability for the duration of the study,
2. Male or female subjects, ≥18 years of age,
3. ECOG performance status (ECOG PS, Appendix 15.1) ≤2,
4. Unresectable metastatic RAS mutant (either KRAS or NRAS tumor gene mutation)
colorectal cancer,
5. At least one (≥1) measurable and/or evaluable liver metastasis,
6. Prior therapy (resistant or intolerant) with fluoropyrimidines, oxaliplatin,
irinotecan and antiangiogenic agent (ie, bevacizumab and/or aflibercept),
7. 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,
8. Negative pregnancy test within 7 days prior to initiation of the study drug for
female patients of childbearing potential,
9. Effective contraception for both male and female subjects if the risk of conception
exists
10. Registration in a national health care system.
1. Known allergy or hypersensitivity reactions to any study drug,
2. Women who are pregnant or breastfeeding,
3. Inability to comply with study and follow-up procedures as judged by the
Investigator,
4. Patient with BRAF mutant colorectal cancer
5. History of interstitial lung disease
6. 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
7. 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
8. Treatment with strong UGT1A inhibitors (e.g. atazanavir, gemfibrozil, indinavir) for
patients of cohort # 2
9. Patients of cohort #2 with known UGT1A deficiency
10. 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.
11. Patient with current intestinal obstruction or history of chronic inflammatory bowel
disease
12. Subjects under guardianship, curatorship or judicial protection