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

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.

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