N/A
Completed N=19
Fat Emulsion in Preventing Hypersensitivity Reactions in Patients With Cancer Receiving Carboplatin or Oxaliplatin
Advanced Malignant Neoplasm
Source: ClinicalTrials.gov NCT03122886 ↗
Enrolled (actual)
19
Serious AEs
18.8%
Results posted
May 2020
Primary outcomePrimary: Time-to-carboplatin or Oxaliplatin Acute Hypersensitivity Reaction — 4.4; NA months — p=0.90
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-to-carboplatin or Oxaliplatin Acute Hypersensitivity Reaction |
4.4; NA | 0.90 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03122886). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.