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

Yale University

Status and phase

Completed

Phase 1

Conditions

Colon Cancer

Treatments

Drug: Omalizumab

Study type

Interventional

Funder types

Other

Identifiers

NCT02266355

1408014510

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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