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 - The E-Rechallenge Trial

Public Health Research Foundation0 sites50 target enrollmentFebruary 4, 2015

ConditionsColorectal cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Colorectal cancer
Sponsor: Public Health Research Foundation
Enrollment: 50
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 4, 2015

End Date

December 31, 2017

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Public Health Research Foundation

Eligibility Criteria

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.