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

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02266355
• Other study ID #: 1408014510
• Status: Completed
• Phase: Phase 1
• Start date: November 2014
• Est. completion date: February 27, 2018

Study information

• Verified date: May 2019
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 27, 2018
• Est. primary completion date: February 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Hypersensitivity

Intervention

Drug:
• Omalizumab
Omalizumab 300 mg SQ every 2 weeks

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Recurrent HSR	Recurrent Oxaliplatin HSR in subjects treated with omalizumab	up to 12 months
Secondary	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