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

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.

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