Role of Omalizumab in Reducing the Incidence of Oxaliplatin-induced Hypersensitivity Reaction

Phase 1

Completed

• Conditions: Colon Cancer
• Interventions: Drug: Omalizumab

• Registration Number: NCT02266355
• Lead Sponsor: Yale University

Brief Summary

Pilot study to evaluate the activity of omalizumab in the prevention of recurrent oxaliplatin hypersensitivity reaction (HSR) in oxaliplatin-sensitive patients. The study will also evaluate the safety of omalizumab (Xolair) when administered in this setting.

Detailed Description

This is an open label single arm pilot study studying the effects of omalizumab in the treatment of oxaliplatin hypersensitivity reaction (HSR) for patients with stage IV GI cancer.

Study Timeline

• Study First Submitted: 2014-10-10
• Study First Submitted QC: 2014-10-16
• Study First Posted: 2014-10-17
• Study Start: 2014-11
• Primary Completion: 2018-02-27
• Study Completion: 2018-02-27
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-28
• Last Update Posted: 2019-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Clinically evident HSR to oxaliplatin, with symptoms of flushing, urticaria, pruritus, rash, and/or dyspnea without bronchospasm that emerge during or shortly after of oxaliplatin infusion
• Responding (complete or partial) or stable disease according to RECIST criteria while undergoing treatment with oxaliplatin containing regimen or need to resume an oxaliplatin based regimen in the setting of well-documented recent oxaliplatin hypersensitivity reaction
• Histologically confirmed stage IV GI cancer (AJCC 7th edition) currently sensitive to oxaliplatin containing chemotherapy regimen
• Age 18 years or older
• ECOG performance status 0-2
• Adequate bone marrow, liver, and kidney function. (WBC > 1500 cells/uL, platelets > 50,000/uL, ALT/AST < 5xULN (unless due to liver metastasis), Creatinine < 2.0 mg/ld)
• Willing to give written informed consent, adhere to the visit schedules and meet study requirements

Exclusion Criteria

• Prior history of severe reactions to oxaliplatin as characterized by the presence of hemodynamic instability, significant respiratory symptoms or potential airway compromise
• History of hypersensitivity reaction to Xolair or any ingredient of Xolair
• Concurrent therapy with investigational agents
• Use of any other investigational agent in the last 15 days and all toxicity of prior therapy resolved
• Psychological, familial, or sociological condition potentially hampering compliance with the study protocol and follow-up schedule
• Women of childbearing potential not using the contraception method(s), as well as women who are breastfeeding
• Patients with severe medical conditions that in the view of the investigator prohibits participation in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OmalizumabTreatment Group	Omalizumab	Omalizumab (Xolair) 300 mg SQ every 2 weeks

Primary Outcome Measures

Name	Time	Method
Incidence of Recurrent HSR	up to 12 months	Recurrent Oxaliplatin HSR in subjects treated with omalizumab

Secondary Outcome Measures

Name	Time	Method
Safety of Omalizumab	up to 12 months	Evaluate the safety of omalizumab by assessment of frequency of adverse events and serious adverse events as categorized by CTCAE version 4

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States