Advanced Malignant Neoplasm
Conditions
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.
Interventions
DIETARY_SUPPLEMENTFat Emulsion
Given IV
OTHERPlacebo
Given IV
Sponsors
National Cancer Institute (NCI)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 9 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Group II (Placebo) | Total | Group I (Fat Emulsion) |
|---|---|---|---|
| Age, Continuous | 66 years | 66 years | 67.5 years |
| ECOG Performance Status 0 | 3 Participants | 11 Participants | 8 Participants |
| ECOG Performance Status 1 | 6 Participants | 8 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 19 Participants | 10 Participants |
| Sex: Female, Male Female | 7 Participants | 15 Participants | 8 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 7 |
| other Total, other adverse events | 4 / 9 | 2 / 7 |
| serious Total, serious adverse events | 1 / 9 | 2 / 7 |
Outcome results
Primary
Time-to-carboplatin or Oxaliplatin Acute Hypersensitivity Reaction
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.
Time frame: Up to 2 years
Population: Evaluable participants are included in this analysis (i.e. exclude Withdrawals).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group I (Fat Emulsion) | Time-to-carboplatin or Oxaliplatin Acute Hypersensitivity Reaction | 4.4 months |
| Group II (Placebo) | Time-to-carboplatin or Oxaliplatin Acute Hypersensitivity Reaction | NA months |
p-value: 0.995% CI: [0.12, 6.37]Log Rank