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

Overview

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.

Full Title of Study: “Double-Blinded, Placebo-Controlled Pilot Trial to Explore Whether Lipids Prevent Carboplatin and Oxaliplatin Hypersensitivity Reactions”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 31, 2019

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.

Interventions

  • Dietary Supplement: Fat Emulsion
    • Given IV
  • Other: Placebo
    • Given IV

Arms, Groups and Cohorts

  • Experimental: Group I (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.
  • Placebo Comparator: Group II (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.

Clinical Trial Outcome Measures

Primary Measures

  • Time-to-carboplatin or Oxaliplatin Acute Hypersensitivity Reaction
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Aminah Jatoi, Principal Investigator, Mayo Clinic

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.