Colorectal cancer
Conditions
Interventions
administration of Cetuximab
Sponsors
Public Health Research Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with colorectal cancer histologically classified as adenocarcinoma. 2)Patients in whom tumor positivity for wild-type RAS has been confirmed. 3)Patients with incurable, unresectable, progressive/recurrent cancer. 4)Patients with a measurable lesion according to RECIST (version 1.1). 5)Patients who have not undergone thoracotomy, laparotomy, or radiation therapy within 4 weeks before the start of protocol treatment (except for procedures related to a stoma or CV port and irradiation limited to approximately one vertebral body). 6) Patients who have not received any anticancer treatment within 2 weeks before the start of protocol treatment. 7) Patients whose tumors have become refractory to treatment with fluoropyrimidines, oxaliplatin, irinotecan, cetuximab or bevacizumab (or who have become intolerant of these agents, except irinotecan and cetuximab). 8) Patients who achieved CR, PR, or SD persisting for >=6 months as the best effect of previous treatment with cetuximab. 9) Patients who have received treatment with 1 or 2 regimens not including anti-EGFR antibody agents after previous treatment with cetuximab. 10) Patients in whom there is an interval >=16 weeks between the last dose of cetuximab during previous treatment and the scheduled date of cetuximab rechallenge (the start of protocol treatment). 11) Patients aged >=20 years at the time of giving informed consent. 12) Patients with an ECOG performance status (PS) of 0-1. 13) Patients in whom laboratory tests performed within 14 days before enrollment (including testing on the day exactly two weeks before enrollment) show satisfactory function of the following major organs, except those who received blood transfusion or treatment with hematopoietic growth factors such as G-CSF within 14 days before testing. 14) Patients who are negative for HBsAg. 15) Patients who are expected to survive for >=3 months. 16) Patients who received a full explanation about this study and gave written consent
Exclusion criteria
Exclusion criteria: 1) Patients with severe diarrhea (watery stools). 2) Patients with active infection (requiring treatment with intravenous antibiotics or antibacterial agents, antifungal agents, or antiviral agents) or with HIV infection. 3) Patients with fluid in a body cavity (such as a pleural effusion, ascites, or pericardial effusion) that requires treatment. 4) Patients with clinical evidence of coronary artery disease, myocardial infarction within 12 months before enrollment, or a poorly controlled arrhythmia or cardiac dysfunction. 5) Patients with pulmonary fibrosis, an acute lung disorder, or interstitial pneumonitis (or a history of any of these conditions). 6) Patients with intestinal paralysis or obstruction. 7) Patients with jaundice or hepatic failure. 8) Patients on treatment with atazanavir sulfate. 9) Patients with uncontrolled diabetes mellitus, malignant hypertension, or hypercalcemia. 10) Patients with symptomatic brain metastasis. 11) Patients with a history of hypersensitivity to cetuximab or irinotecan. 12) Patients with synchronous double cancer or with metachronous double cancer and a disease-free interval <=5 years (except for skin cancer and early gastrointestinal cancer likely to be cured by endoscopic mucosal resection). 13) Men who are unwilling to use contraception, and pregnant women, nursing mothers, women with positive pregnancy test, or women unwilling to use contraception. 14) Other patients who the investigator judges to be unsuitable as subjects of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate (RR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) Overall survival (OS) Association between the anti-EGFR antibody-free interval (aEFI) and the response rate Safety (frequency and severity of adverse events) | — |
Countries
Japan
Contacts
Public ContactEiji Shinozaki
Japanese Foundation for Cancer Research, Cancer Institute Hospital, Gastroenterology Center Department of Gastroenterology
Outcome results
None listed