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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Study of the Role of Omalizumab (Xolair) in Reducing the Incidence of Oxaliplatin-induced Hypersensitivity Reaction (HSR)

Conditions
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Colon Cancer

Intervention / Treatment
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* Drug: Omalizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OmalizumabTreatment Group<br>Omalizumab (Xolair) 300 mg SQ every 2 weeks | Drug: Omalizumab<br>* Omalizumab 300 mg SQ every 2 weeks<br>* Other names: Xolair;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Recurrent HSR | Recurrent Oxaliplatin HSR in subjects treated with omalizumab | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Omalizumab | Evaluate the safety of omalizumab by assessment of frequency of adverse events and serious adverse events as categorized by CTCAE version 4 | up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxaliplatin, Omalizumab