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