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

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Group I (fat emulsion)	Fat Emulsion	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.
Group II (placebo)	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Time-to-carboplatin or Oxaliplatin Acute Hypersensitivity Reaction	Up to 2 years	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.

Secondary Outcome Measures