Gastrointestinal Cancer, Nausea Post Chemotherapy
Conditions
Brief summary
This clinical trial studies fosaprepitant dimeglumine in preventing nausea and vomiting in patients with gastrointestinal cancer receiving combination chemotherapy. Antiemetic drugs, such as fosaprepitant dimeglumine, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy.
Detailed description
PRIMARY OBJECTIVES: I. To evaluate efficacy of the addition of fosaprepitant (fosaprepitant dimeglumine) in controlling acute and delayed vomiting with the standard prophylactic anti-emetic combination of 5-HT3 receptor antagonist and dexamethasone for gastrointestinal cancer patients receiving FOLFIRINOX (5-FU \[fluorouracil\], oxaliplatin and irinotecan \[irinotecan hydrochloride\]) chemotherapy. II. To determine the rate of complete response (no emetic episode and no rescue medication) in the combined acute and delayed phase from 0-120 hours after chemotherapy. SECONDARY OBJECTIVES: I. To determine the incidence of nausea and vomiting in both acute (\< 24 hours) and delayed (24- 120 hours) setting in patients receiving FOLFIRINOX chemotherapy. TERTIARY OBJECTIVES: I. Follow overall survival in patients receiving FOLFIRINOX chemotherapy. OUTLINE: Patients receive fosaprepitant dimeglumine intravenously (IV) 30 minutes prior to FOLFIRINOX chemotherapy. After completion of study treatment, patients are followed up for 2 months.
Interventions
Given IV
Sponsors
National Cancer Institute (NCI)
Philip Philip
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient receiving FOLFIRINOX chemotherapy * Southwest Oncology Group (SWOG) Performance status 0 or 1 * Ability of patient or guardian to understand and to provide voluntary written informed consent
Exclusion criteria
* Patient with current illness requiring chronic systemic steroids use or requiring chronic use of anti emetics * Patients with gastrointestinal (GI) obstruction or active peptic ulcer disease who cannot take oral medication * Known hypersensitivity to any component of the study regimen * Patients taking any of the following medications: Oral contraceptives (except for the administration of stopping menses), tolbutamide, phenytoin, midazolam, ketoconazole, rifampin, paroxetine, and Diltiazem * Pregnant or nursing women * Patients using illegal drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Control of Vomiting and Rescue Medication Control | From 0-120 hours after first course of chemotherapy | Achieved if a patient has no episodes of vomiting and requires no rescue medication during the first 120 hours after fosaprepitant dimeglumine administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Control of Both Acute and Delayed Vomiting | in approximately 28 months | Achieved if a patient has no episodes of vomiting at both 24 and 120 hours after fosaprepitant dimeglumine administration. |
| Percentage of Participants With Control of Both Acute and Delayed Nausea | in approximately 28 months | Achieved if a patient has no episodes of nausea at both 24 and 120 hours after fosaprepitant dimeglumine administration. |
| Overall Survival | Time of initiation of treatment until death or censor assessed up to 26 months | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment (Nausea and Vomiting Prophylaxis) Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy.
fosaprepitant dimeglumine: Given IV | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | Treatment (Nausea and Vomiting Prophylaxis) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants |
| Age, Continuous | 56.0 years STANDARD_DEVIATION 9.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment United States | 27 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 22 / 27 |
| other Total, other adverse events | 12 / 27 |
| serious Total, serious adverse events | 3 / 27 |
Outcome results
Primary
Percentage of Participants With Control of Vomiting and Rescue Medication Control
Achieved if a patient has no episodes of vomiting and requires no rescue medication during the first 120 hours after fosaprepitant dimeglumine administration.
Time frame: From 0-120 hours after first course of chemotherapy
Population: The analysis set includes patients (n=26) who returned an outcomes diary at 24 or 120 hours post treatment. 1 patient could not be evaluated as they did not return their diary.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Nausea and Vomiting Prophylaxis) | Percentage of Participants With Control of Vomiting and Rescue Medication Control | 26.9 percentage of participants |
Secondary
Overall Survival
Time frame: Time of initiation of treatment until death or censor assessed up to 26 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment (Nausea and Vomiting Prophylaxis) | Overall Survival | 11.5 months |
Secondary
Percentage of Participants With Control of Both Acute and Delayed Nausea
Achieved if a patient has no episodes of nausea at both 24 and 120 hours after fosaprepitant dimeglumine administration.
Time frame: in approximately 28 months
Population: The analysis set includes patients (n=25) who returned an outcomes diary at 24 or 120 hours post treatment with nausea information filled out. 2 patients could not be evaluated as they did not return their diary with nausea information filled out.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Nausea and Vomiting Prophylaxis) | Percentage of Participants With Control of Both Acute and Delayed Nausea | 28.0 percentage of participants |
Secondary
Percentage of Participants With Control of Both Acute and Delayed Vomiting
Achieved if a patient has no episodes of vomiting at both 24 and 120 hours after fosaprepitant dimeglumine administration.
Time frame: in approximately 28 months
Population: The analysis set includes patients (n=26) who returned an outcomes diary at 24 or 120 hours post treatment. 1 patient could not be evaluated as they did not return their diary.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Nausea and Vomiting Prophylaxis) | Percentage of Participants With Control of Both Acute and Delayed Vomiting | 65.4 percentage of participants |