Phase II Clinical Study Evaluating the Efficacy and Safety of Cetuximab Rechallenge in Patients with Wild-Type RAS, Unresectable, Progressive/Recurrent Colorectal Cancer Refractory to Fluoropyrimidines, Oxaliplatin, Irinotecan, Cetuximab and Bevacizumab: The E-Rechallenge Trial

Phase 2

• Conditions: Colorectal cancer

• Registration Number: JPRN-UMIN000016439
• Lead Sponsor: Public Health Research Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-04
• Study Completion: 2017-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate (RR)

Secondary Outcome Measures

Name	Time	Method
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)