Clinical trial · Observational
Prospective Analysis of Hypersensitivity Reactions to Oxaliplatin
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Small Bowel Cancer | Small Intestinal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- All Participants
- description
- Patients receiving Oxaliplatin
- label
- Desensitization
- description
- Patients that have experienced a moderate to severe hypersensitivity reaction to oxaliplatin
Primary outcomes (1)
- measure
- To determine prospectively the incidence and severity of hypersensitivity reactions to oxaliplatin among patients beginning treatment with oxaliplatin during a two-year observation period.
- timeFrame
- 2 years
Secondary outcomes (3)
- measure
- To determine the relationship between cumulative dose of oxaliplatin and duration of therapy and development of hypersensitivity reactions.
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or older * Histologically or cytologically confirmed colorectal cancer, esophageal cancer, gastric cancer, small bowel cancer, hepatobiliary cancer and pancreatic cancer * Patients must be eligible for treatment with oxaliplatin * ECOG Performance Status of 2 or less * Adequate bone marrow, renal and hepatic function as outlined in the protocol * Patients must have recovered from both the acute and late effects of any prior surgery, radiotherapy or other antineoplastic therapy * Patients may participate in monitoring for hypersensitivity and skin testing if they are receiving oxaliplatin as part of another clinical trial and allowed by that trial. Patients cannot receive oxaliplatin through the desensitization protocol if they are part of another clinical trial. Exclusion Criteria: * Prior treatment with oxaliplatin * Active infection or with a fever of 101.3 or higher within 3 days of the first scheduled days of protocol treatment * Patients with active CNS metastases. Patients with stable CNS disease, who have undergone radiotherapy at least 4 weeks prior to the planned first protocol treatment and who have been on a stable dose of corticosteroids for greater than 3 weeks are eligible. * Patients with known hypersensitivity to any of the components of oxaliplatin or chemotherapeutic agent used in combination with oxaliplatin * Patients who have received radiotherapy to more than 25% of their bone marrow; or patients who received any radiotherapy within 4 weeks of study entry * Peripheral neuropathy of grade 2 or higher * Patients who are pregnant or lactating * Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the patient's ability to sign informed consent, cooperate and participate in teh study, or interfere with the interpretation of the results.
References
Publications (0)
Data not yet available