A Phase 2 interventional study of fosaprepitant dimeglumine and cisplatin in Nausea and Vomiting, Stage III Squamous Cell Carcinoma of the Hypopharynx and Stage III Squamous Cell Carcinoma of the Larynx, sponsored by University of Washington. Terminated at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-05-18.
Sponsored by University of Washington · Phase 2, Interventional, and Supportive care
RATIONALE: Fosaprepitant dimeglumine, palonosetron hydrochloride, and dexamethasone may help lessen or prevent nausea and vomiting caused by cisplatin in patients with head and neck cancer undergoing chemotherapy and radiation therapy.
PURPOSE: This phase II trial is studying how well fosaprepitant dimeglumine together with palonosetron hydrochloride and dexamethasone works in preventing nausea and vomiting caused by cisplatin in patients with stage III or stage IV head and neck cancer undergoing chemotherapy and radiation therapy.
PRIMARY OBJECTIVES:
I. To determine the complete response rate of anti-emetic therapy based on a single dose of intravenous fosaprepitant with multiple cycles of high dose cisplatin (complete response is defined as no emesis or rescue nausea medications needed in the 120 hours following cisplatin infusion).
SECONDARY OBJECTIVES:
I. To determine the complete response rate of anti-emetic therapy based on a single dose of intravenous fosaprepitant with multiple cycles of high dose cisplatin in the delayed period (25-120 hours following cisplatin infusion).
II. To determine efficacy of anti-emetic therapy based on a single-dose of intravenous fosaprepitant to achieve adequate control of nausea following multiple cycles of high-dose cisplatin as defined by a score on the visual analog scale of \< 25mm in the 120 hours following cisplatin infusion.
III. To determine the functional impact of cisplatin induced nausea and vomiting (CINV) on daily life as measured by the Functional Living Index-Emesis (FLIE) Questionnaire total score.
OUTLINE: Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients also undergo 3-D conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for up to 7 weeks.
Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1 (prior to cisplatin infusion). Patients then receive oral dexamethasone on days 2-4. Patients with no emesis or requirement for rescue anti-emetics in the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin.
Patients complete an emesis diary (that includes a nausea visual analog scale) daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 of each course of chemotherapy.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 6 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
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Exclusion Criteria:
Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients also undergo radiotherapy once daily 5 days a week for up to 7 weeks. Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients then receive oral dexamethasone on days 2-4. Patients with no emesis or requirement for rescue anti-emetics in the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin. Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.
Drug: fosaprepitant dimeglumine · Drug: cisplatin · Drug: palonosetron hydrochloride · Drug: dexamethasone · Other: Functional Living Index-Emesis Questionnaire · Behavioral: Emesis Diary · Radiation: Radiotherapy
Given IV
Given IV
Also known as: CACP, CDDP, CPDD, DDP, Neoplatin
Given IV
Also known as: Aloxi, RS 25259-197
Given IV and orally
Also known as: Aeroseb-Dex, Decaderm, Decadron, Decaspray, DM, DXM
Ancillary studies
Ancillary studies
Undergo radiotherapy
Also known as: 3-D conformal radiotherapy or IMRT
Proportion of Patients With a Complete Response to the Anti-emetic Medication Regimen
Complete response is defined as no emesis or rescue nausea medications needed in the first 120 hours following cisplatin infusion.
Time frame: 120 hours following cisplatin infusion
Rate of Complete Response to Anti-emetic Therapy in the Delayed Setting (25-120 Hours After Cisplatin Infusion)
Time frame: 25-120 hours following cisplatin infusion
Control of Nausea for 120 Hours Following Each Cisplatin Infusion for Multiple Cycles of Therapy as Measured by the Visual Analog Scale
The visual analog scale ranges from 0-100. 0 is labeled as "no nausea" and 100 is labeled as "nausea as bad as it could be" A score of \< 25 is considered to indicate no significant nausea. All patients discontinued trial after only one cisplatin infusion.
Time frame: 120 hours following cisplatin infusion
Impact of Cisplatin-induced Nausea and Vomiting on Daily Life During the 5 Day Period Following Cisplatin Infusion for Multiple Cycles as Measured by the Functional Living Index-Emesis Questionnaire
FLIE is a patient-completed quality of life assessment modified from the original Functional Living Index - Cancer questionnaire. FLIE contains two domains: nausea and vomiting with nine items in each domain. The first item asks the patient to rate how much nausea (or vomiting) has occurred over a 5 day period. The remaining eight items ask patients to rate the impact of nausea (or vomiting) on various aspects of a patient's life (for example, ability to enjoy meals/liquids). Each item is answered using a 7 point visual analog scale with 7 being "none /not at all" and 1 being "a great deal". The two domains are summed for a total score with a possible range of 18-126. Higher scores indicate a more favorable quality of life. A total score of \>108 defines those patients who had a minimal impact of CINV on quality of life. All particpants discontinued the trial after one cycle of cisplatin.
Time frame: 5 days following cisplatin infusion
Patients with Head and neck cancer being treated with concurrent cisplatin and radiotherapy were approached for study participation.
| Milestone | Arm I |
|---|---|
| Started | 6 |
| Completed | 0 |
| Not completed | 6 |
| Withdrew: Lack of efficacy | 6 |
Complete response is defined as no emesis or rescue nausea medications needed in the first 120 hours following cisplatin infusion.
| Participants | Arm I |
|---|---|
| Proportion of Patients With a Complete Response to the Anti-emetic Medication Regimen | 0 |
| Participants | Arm I |
|---|---|
| Rate of Complete Response to Anti-emetic Therapy in the Delayed Setting (25-120 Hours After Cisplatin Infusion) | 0 |
The visual analog scale ranges from 0-100. 0 is labeled as "no nausea" and 100 is labeled as "nausea as bad as it could be" A score of \< 25 is considered to indicate no significant nausea. All patients discontinued trial after only one cisplatin infusion.
| millimeters | Arm I |
|---|---|
| Control of Nausea for 120 Hours Following Each Cisplatin Infusion for Multiple Cycles of Therapy as Measured by the Visual Analog Scale | 45.2 (6 to 79) |
FLIE is a patient-completed quality of life assessment modified from the original Functional Living Index - Cancer questionnaire. FLIE contains two domains: nausea and vomiting with nine items in each domain. The first item asks the patient to rate how much nausea (or vomiting) has occurred over a 5 day period. The remaining eight items ask patients to rate the impact of nausea (or vomiting) on various aspects of a patient's life (for example, ability to enjoy meals/liquids). Each item is answered using a 7 point visual analog scale with 7 being "none /not at all" and 1 being "a great deal". The two domains are summed for a total score with a possible range of 18-126. Higher scores indicate a more favorable quality of life. A total score of \>108 defines those patients who had a minimal impact of CINV on quality of life. All particpants discontinued the trial after one cycle of cisplatin.
| units on a scale | Arm I |
|---|---|
| Impact of Cisplatin-induced Nausea and Vomiting on Daily Life During the 5 Day Period Following Cisplatin Infusion for Multiple Cycles as Measured by the Functional Living Index-Emesis Questionnaire | 83.98 (70.81 to 98.94) |
Collected over up to 7 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I | — | 0/6 (0%) | 6/6 (100%) |
| Event | Arm I |
|---|---|
| nauseaGastrointestinal disorders | 5/6 |
| leukocytesBlood and lymphatic system disorders | 4/6 |
| VomitingGastrointestinal disorders | 3/6 |
| MucositisGastrointestinal disorders | 2/6 |
| TinnitusEar and labyrinth disorders | 1/6 |
| AnorexiaGeneral disorders | 1/6 |
| HeadacheNervous system disorders | 1/6 |
| DizzinessEar and labyrinth disorders | 1/6 |
| AtaxiaNervous system disorders | 1/6 |
| MalaiseGeneral disorders | 1/6 |
| Age, Categorical(Participants) | Arm I |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 6 |
| >=65 years | 0 |
| Age, Continuous(years) | Arm I |
|---|---|
| Median | 41 (39 to 51) |
| Sex: Female, Male(Participants) | Arm I |
|---|---|
| Female | 3 |
| Male | 3 |
| Region of Enrollment(participants) | Arm I |
|---|---|
| United States | 6 |
Plan to share: No
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