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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-03735 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| P30 CA022453I | Other Identifier | National Institutes of Health | |
| P30CA022453 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (nausea and vomiting prophylaxis) | Experimental | Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fosaprepitant dimeglumine | Drug | Given IV |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From 0-120 hours after first course of chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | in approximately 28 months |
| Percentage of Participants With Control of Both Acute and Delayed Nausea |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip A. Philip, M.D., Ph.D., F.R.C.P | Barbara Ann Karmanos Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Nausea and Vomiting Prophylaxis) | Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy. fosaprepitant dimeglumine: Given IV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 17, 2014 |
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Achieved if a patient has no episodes of nausea at both 24 and 120 hours after fosaprepitant dimeglumine administration. |
| in approximately 28 months |
| Overall Survival | Time of initiation of treatment until death or censor assessed up to 26 months |
| COMPLETED |
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| NOT COMPLETED |
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30 patients were eligible and consented to this protocol. 3 of these patients never began treatment, leaving our final analysis number at 27.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Nausea and Vomiting Prophylaxis) | Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy. fosaprepitant dimeglumine: Given IV |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | 90% Confidence Interval | percentage of participants | From 0-120 hours after first course of chemotherapy |
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| 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. | 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. | Posted | Number | 90% Confidence Interval | percentage of participants | in approximately 28 months |
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| 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. | 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. | Posted | Number | 90% Confidence Interval | percentage of participants | in approximately 28 months |
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| Secondary | Overall Survival | Posted | Median | 90% Confidence Interval | months | Time of initiation of treatment until death or censor assessed up to 26 months |
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The adverse event information includes unexpected and/or serious adverse events from cycles 1 and 2 of treatment. As each cycle last approximately 2 weeks, the adverse event information in this report covers the first month of treatment. The mortality information includes death events while the patients were on treatment or in follow-up (up to 27 months).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | All participants | 22 | 27 | 3 | 27 | 12 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI bleed from gastric ulcer | Gastrointestinal disorders | Non-systematic Assessment |
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| Uncontrolled nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| bowel obstruction | Gastrointestinal disorders | Non-systematic Assessment |
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| intractable nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Hypokalemia | General disorders | Non-systematic Assessment |
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| Dehydration | General disorders | Non-systematic Assessment |
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| Anemia | General disorders | Non-systematic Assessment |
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| Hyponatremia | General disorders | Non-systematic Assessment |
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| Decreased white blood cell count | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Philip A. Philip, M.D., Ph.D., F.R.C.P | Barbara Ann Karmanos Cancer Institute | (313)576-8624 | philipp@karmanos.org |
| Aug 19, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C579707 | fosaprepitant |
| D000077608 | Aprepitant |
| ID | Term |
|---|---|
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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