Colon Cancer
Conditions
Keywords
Oxaliplatin, Omalizumab
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.
Interventions
DRUGOmalizumab
Omalizumab 300 mg SQ every 2 weeks
Sponsors
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Recurrent HSR | up to 12 months | Recurrent Oxaliplatin HSR in subjects treated with omalizumab |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed