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| ID | Type | Description | Link |
|---|---|---|---|
| SANOFI OX-07-008 |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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This research study will examine how often hypersensitivity, or allergic reactions, occur in patients receiving the chemotherapy medication oxaliplatin. Hypersensitivity reactions can vary from a transient skin rash and fever to more severe symptoms such as shortness of breath, chest tightness, and a more severe allergic reaction that can affect blood pressure called anaphylaxis. We will be examining how often hypersensitivity reactions occur and how severe the reactions are when they occur. We will also examine whether there are factors that place people at risk for developing hypersensitivity reactions to oxaliplatin. In an optional portion to this study, we will examine whether allergy skin testing can predict whether someone will develop a hypersensitivity reaction.
Participants who develop a moderate to severe allergic reaction to oxaliplatin will be invited to participate in an additional portion of the study examining a desensitization process. This part of the study will examine whether a desensitization process can prevent future hypersensitivity reactions to oxaliplatin in patients who previously developed moderate to severe hypersensitivity reactions and allow therapy with oxaliplatin to continue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | Patients receiving Oxaliplatin | ||
| Desensitization | Patients that have experienced a moderate to severe hypersensitivity reaction to oxaliplatin |
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| Measure | Description | Time Frame |
|---|---|---|
| To determine prospectively the incidence and severity of hypersensitivity reactions to oxaliplatin among patients beginning treatment with oxaliplatin during a two-year observation period. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the relationship between cumulative dose of oxaliplatin and duration of therapy and development of hypersensitivity reactions. | 2 years | |
| To determine the ability of oxaliplatin skin testing to identify patients at risk for developing hypersensitivity reactions. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated at Dana-Farber Cancer Institute with the chemotherapy drug oxaliplatin.
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer A. Chan, MD, MPH | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| 2 years |
| To determine the safety and efficacy of a rapid desensitization protocol to allow responding patients with moderate to severe hypersensitivity reactions to oxaliplatin to continue therapy with the drug. | 2 years |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D013272 | Stomach Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D007154 | Immune System Diseases |