Fat Emulsion in Preventing Hypersensitivity Reactions in Patients With Cancer Receiving Carboplatin or Oxaliplatin

Study Overview
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Brief Summary
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This randomized pilot trial studies how well fat emulsion works in preventing hypersensitivity reactions in patients with cancer receiving carboplatin or oxaliplatin. Giving lipids before chemotherapy may prevent some drug reactions from carboplatin or oxaliplatin.

Detailed Description
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PRIMARY OBJECTIVES: I. To determine if the infusion of a lipid emulsion before each dose of chemotherapy appears to prevent carboplatin and oxaliplatin hypersensitivity reactions in high-risk patients. II. To explore if lipid infusions modulate a well-established panel of mediators of hypersensitivity reactions and if these mediators appear to predict reactions. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive fat emulsion intravenously (IV) immediately before each dose of either carboplatin or oxaliplatin. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity. GROUP II: Patients receive placebo IV immediately before each dose of either carboplatin or oxaliplatin. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.

Official Title
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Double-Blinded, Placebo-Controlled Pilot Trial to Explore Whether Lipids Prevent Carboplatin and Oxaliplatin Hypersensitivity Reactions

Conditions
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Advanced Malignant Neoplasm

Intervention / Treatment
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* Dietary Supplement: Fat Emulsion
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Advanced, incurable cancer 7th or later cycle of intravenous carboplatin or oxaliplatin infusion planned or 4 months after the first cycle of agent (whichever is of longer duration) =< 30 days after registration Anticipated 2 or more subsequent chemotherapy infusions of either carboplatin or oxaliplatin at the time of study registration; NOTE: the dose of carboplatin or oxaliplatin, choice of other chemotherapy, and other ancillary treatment, such as antiemetics, will be left to the discretion of the treating healthcare provider Willing to provide mandatory blood and urine specimens for correlative research; NOTE: can be waived with permission of study chair (documentation such as an email must be provided) Serum creatinine =< 1.5 times the institutional upper limit of normal (ULN); NOTE: can be waived with permission of study chair (documentation such as an email must be provided) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x the upper limit of normal Triglycerides < 500 mg/dL Alkaline phosphatase =< 3 x the institutional upper limit of normal Exclusion Criteria: Concurrent liposomal doxorubicin or any other liposomal agent Prior carboplatin or oxaliplatin hypersensitivity reaction Taking aspirin, nonsteroidal anti-inflammatory agents, or zileuton =< 7 days prior to registration; NOTE: can be waived with permission of study chair (documentation such as an email must be provided) Allergy to egg or egg byproducts

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (fat emulsion)<br>Patients receive fat emulsion IV immediately before each dose of either carboplatin or oxaliplatin. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity. | Dietary Supplement: Fat Emulsion<br>* Given IV<br>* Other names: Intravenous Fat Emulsion;|
| Placebo Comparator: Group II (placebo)<br>Patients receive placebo IV immediately before each dose of either carboplatin or oxaliplatin. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity. | Other: Placebo<br>* Given IV<br>* Other names: sham therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to-carboplatin or Oxaliplatin Acute Hypersensitivity Reaction | The primary endpoint is the time to healthcare provider reported hypersensitivity reactions from either carboplatin or oxaliplatin. Kaplan Meier curves will be constructed and a log-rank test will be used to compare time-to-hypersensitivity reaction between treatment arms. Data will be censored based on last infusion with no hypersensitivity reaction with a maximum study treatment duration of 2 years per patient. | Up to 2 years |