Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nausea

Vomiting

Genital Neoplasms, Female

Signs and Symptoms, Digestive

Urogenital Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Palonosetron

Fosaprepitant

Aprepitant

Cisplatin

Dexamethasone acetate

Serotonin

Substance P

Neurokinin A

Serotonin Receptor Agonists

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Serotonin 5-HT3 Receptor Antagonists

Neurotransmitter Agents

Neurokinin-1 Receptor Antagonists

Addition of fosaprepitant dimeglumine 150 mg IV single dose weekly (before chemotherapy) to dexamethasone and palonosetron.

Fosaprepitant dimeglumine

Placebo

Jorn Herrstedt, MD, DMSci

Christina Ruhlmann, MD

Dorothy Keefe, MD, FRACP

Petra Feyer, MD, DMSci

Thomas Broe Christensen, MD, PhD

Gunnar Kristensen, MD, PhD

Henrik Roed, MD, DMSci

Felix Hilpert, MD, DMSci

Jacob C Lindegaard, MD

GAND-emesis is a multinational, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy and tolerability of a neurokinin1 receptor antagonist (fosaprepitant dimeglumine) in combination with an antiemetic (anti-nausea-and-vomiting) control regimen (palonosetron and dexamethasone) in patients with a gynaecological cancer diagnosis, who are scheduled to receive radiotherapy and weekly chemotherapy.

The study aims at investigating if a three-drug antiemetic regimen is superior to a two-drug regimen (standard treatment) in preventing nausea and vomiting in patients receiving radiotherapy and weekly chemotherapy. A pilot study demonstrated that approximately 50% of patients will experience nausea and vomiting when offered a two-drug antiemetic regimen, and it is expected that addition of a third drug (a neurokinin1 receptor antagonist) can increase the proportion of patients with no vomiting in the course of combined chemo-radiotherapy.

Efficacy of Two Antiemetic Regimens in Patients Receiving Radiotherapy and Concomitant Weekly Cisplatin

A Multinational, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Tolerability of Palonosetron and Dexamethasone Plus Fosaprepitant or Placebo in Patients Receiving Radiotherapy and Weekly Cisplatin.

Helsinn Healthcare SA

Odense University Hospital

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Dermatologic Agents

Antirheumatic Agents

Emetics

Anti-Infective Agents

Ondansetron

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Vincristine

Daunorubicin

Ifosfamide

BB 1101

Isophosphamide mustard

Ichthammol

Mesna

Rolapitant

Mechlorethamine

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Protective Agents

Patients receive treatment as in part I. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

CHEMOTHERAPY: All patients receive doxorubicin IV over 72 hours, mesna IV, and ifosfamide IV over 3 hours on days 1-4 or 1-5. Patients with sarcomas of small cell histology receive vincristine sulfate IV on day 1. Cycles repeat every 3 weeks following blood count and patient recovery from any acute toxicities.

Patients receive dexamethasone IV and ondansetron IV on days 1-5, and fosaprepitant dimeglumine IV over 30 minutes on days 1 of cycle 2. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

CHEMOTHERAPY: All patients receive doxorubicin IV over 72 hours, mesna IV, and ifosfamide IV over 3 hours on days 1-4 or 1-5. Patients with sarcomas of small cell histology receive vincristine sulfate IV on day 1. Cycles repeat every 3 weeks following blood count and patient recovery from any acute toxicities.

Fosaprepitant Dimeglumine

Laboratory Biomarker Analysis

Questionnaire Administration

Rolapitant Hydrochloride

Vincristine Sulfate

Saroj Vadhan

This randomized phase II trial studies how well rolapitant hydrochloride works in preventing nausea/vomiting in patients with sarcoma receiving chemotherapy. Antiemetic drugs, such as rolapitant hydrochloride, may help control or prevent nausea and vomiting in patients treated with chemotherapy.

PRIMARY OBJECTIVE:

I. To evaluate the effect of rolapitant hydrochloride (rolapitant) on nausea/vomiting in patients with sarcoma receiving multi-day highly emetogenic chemotherapy (HEC) regimen of doxorubicin and ifosfamide (AI).

SECONDARY OBJECTIVES:

I. To evaluate the toxicity of rolapitant in patients receiving AI regimen. II. To evaluate the effects of rolapitant on patient reported outcomes.

OUTLINE:

PART I: Patients receive dexamethasone intravenously (IV) daily and ondansetron IV on days 1-5, and rolapitant hydrochloride orally (PO) on day 1.

PART II: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive treatment as in part I. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive dexamethasone IV and ondansetron IV on days 1-5, and fosaprepitant dimeglumine IV over 30 minutes on days 1 of cycle 2. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

CHEMOTHERAPY: All patients receive doxorubicin IV over 72 hours, mesna IV, and ifosfamide IV over 3 hours on days 1-4 or 1-5. Patients with sarcomas of small cell histology receive vincristine sulfate IV on day 1. Cycles repeat every 3 weeks following blood count and patient recovery from any acute toxicities.

Rolapitant Hydrochloride in Preventing Nausea/Vomiting in Patients With Sarcoma Receiving Chemotherapy

Effects of Rolapitant on Nausea/Vomiting in Patients With Sarcoma Receiving Multi-Day Highly Emetogenic Chemotherapy (HEC) With Doxorubicin and Ifosfamide Regimen (AI)

Complete response (CR) no emetic episodes and no rescue medications.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Dexamethasone IV daily for 5 days (12 mg on day 1 and 8 mg on days 2-5), Ondansetron (5HT3 receptor antagonist) 16 mg IV daily for 5 days as standard of care, and Rolapitant, 180 mg was administered PO on Day 1.

Cohort 1

Dexamethasone IV daily for 5 days (12 mg on days 1-5 ), Ondansetron (5HT3 receptor antagonist) 16 mg IV daily for 5 days as standard of care, and Rolapitant, 180 mg was administered PO on Day 1

Cohort 2

Cohort 1 - 8mg Dexamethasone

Cohort 2- 12mg Dexamethasone

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

Saroj Vadhan,MD-Clinical Professor, Cytokine & Supportive Oncology

Dexamethasone IV daily for 5 days (12 mg on days 1-5 ), Ondansetron (5HT3 receptor antagonist) 16 mg IV daily for 5 days as standard of care, and Rolapitant, 180 mg was administered PO on Day 1.

Number of Participants With Complete Response (CR) of Rolapitant Hydrochloride Administered as a Single-dose

Overall Study

A 150 mg dose will be given to study patients as rescue therapy after chemotherapy only in the event of breakthrough nausea or vomiting.

fosaprepitant dimeglumine

Patients will receive chemotherapy on Day 1 of their scheduled therapeutic regimen in combination with the pre-defined standard 5-Hydroxytryptamine-3 (5HT3) antagonist, corticosteroid regimen, with or without benzodiazepine based on published guidelines3 or as clinically indicated

systemic chemotherapy

Prior to the first dose of chemotherapy patients will be instructed on how to complete their patient diary

survey administration

Patients will also be provided the Functional Living Index - Emesis (FLIE) quality of life survey to be completed at time zero and then after 24 hours

quality-of-life assessment

Joseph Bubalo, PharmD, BCPS, BCOP

RATIONALE: Antiemetic drugs, such as fosaprepitant dimeglumine, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy.

PURPOSE: This clinical trial is studying the side effects of fosaprepitant dimeglumine and to see how well it works in treating patients with nausea and vomiting caused by chemotherapy.

OBJECTIVES:

Primary

* To evaluate the efficacy and safety of fosaprepitant dimeglumine in patients with breakthrough chemotherapy-induced nausea and vomiting (CINV) after failing prophylactic antiemetic therapy.

Secondary

* To evaluate toxicity and serious adverse events associated with this regimen in these patients.
* To evaluate the ability of patients to tolerate oral intake.
* To evaluate the health-related quality of life of patients treated with this regimen.
* To evaluate specific side effects associated with this regimen, including pain sensation and/or soreness at the infusion site, headache, dizziness, and somnolence, in these patients .
* To refine the study design for future phase II and III studies of rescue therapy for breakthrough CINV using various secondary endpoints.

OUTLINE: Patients receive chemotherapy in combination with a pre-defined standard 5-Hydroxytryptamine-3 (5-HT3) antagonist or corticosteroid regimen with or without a benzodiazepine on day 1. If breakthrough nausea or vomiting occurs, patients then receive fosaprepitant dimeglumine IV once per standard administration guidelines. Patients with treatment response may receive additional doses of oral aprepitant once on days 2 and 3. Patients with persistent nausea/vomiting after 2 hours and who desire further treatment may receive standard rescue therapy with prochlorperazine, metoclopramide, or haloperidol with or without additional lorazepam until relief, at the discretion of the provider.

Patients complete a diary at baseline, and then at 2, 12, and 24 hours that includes a Visual Analogue Scale (VAS) for nausea; VAS for sedation; and questions about emesis and retching frequency, headache, dizziness, somnolence, and ability to take food and liquids orally. Patients also complete the Functional Living Index-Emesis Quality of Life survey at baseline and at 24 hours.

Fosaprepitant Dimeglumine in Treating Patients With Nausea and Vomiting Caused By Chemotherapy

Pilot Study of Fosaprepitant (MK-0517) for Breakthrough Chemotherapy Induced Nausea and Vomiting

The outcome measure is the number of participants that self report improvement in a nausea score from baseline, prior to fosaprepitant, to 2 hours post dose. This includes only participants who report breakthrough nausea or vomiting after chemotherapy and after receiving prophylactic anti-emetics. The primary outcome is measured using the visual analogue scale, a self report scale from "No Nausea" to "Nausea as bad as it can be"; a value can be indicated anywhere on this scale using a free hand mark by the participant and gauged with ruler by study staff. Any participant that reported a lower value on the scale 2 hours from baseline would be considered in this outcome measure.

The outcome measure is the number of participants that self report improvement in a nausea score from baseline, prior to fosaprepitant, to 12 hours post dose. This includes only participants who report breakthrough nausea or vomiting after chemotherapy and after receiving prophylactic anti-emetics. The primary outcome is measured using the visual analogue scale, a self report scale from "No Nausea" to "Nausea as bad as it can be"; a value can be indicated anywhere on this scale using a free hand mark by the participant and gauged with ruler by study staff. Any participant that reported a lower value on the scale 12 hours from baseline would be considered in this outcome measure.

The outcome measure is the number of participants that self report improvement in a nausea score from 2 hours after receiving fosaprepitant to 24 hours post dose. This includes only participants who report breakthrough nausea or vomiting after chemotherapy and after receiving prophylactic anti-emetics. The outcome is measured using the visual analogue scale, a self report scale from "No Nausea" to "Nausea as bad as it can be"; a value can be indicated anywhere on this scale using a free hand mark by the participant and gauged with ruler by study staff. Any participant reporting a lower value on the scale at the 12 or 24 hour time point would be considered in this outcome measure.

Participants were asked to report any episodes of vomiting before (baseline) and up to 24 hours after receiving Fosaprepitant. The outcome considers the number of participants reporting any episodes of emesis after receiving Fosaprepitant.

Participants with persistent nausea/vomiting after 2 hours and who desired further treatment, received standard rescue therapy at the discretion of provider with prochlorperazine, metoclopramide or haloperidol with or without additional lorazepam until relief

The recommended dose Fosaprepitant (MK-0517) is 115 mg administered intravenously 30 minutes before chemotherapy treatment. In this study, a 150 mg dose will be given to study patients as rescue therapy after chemotherapy only in the event of breakthrough nausea or vomiting. Those participants who did not report episodes of emesis or did not require additional rescue medications are measured in this outcome

Participants meeting this outcome self report experiencing drowsiness at any of the study time points (2, 12 or 24 hours after receiving fosaprepitant).

Participants who self report pain/soreness at drug infusion site, headache, or dizziness at any of the study time points (2, 12, or 24 hours after receiving fosaprepitant) are measured in this outcome.

OHSU Knight Cancer Institute

PharmD

Age, Categorical

* Missing data did affect results for the 24 hour mark
* Lack of control group to measure possible neurokinin-1 antagonist (NK1a) inhibition

Dr. Joseph Bubalo

A 150mg dose of study drug given to participants who experience breakthrough nausea and vomiting after prophylactic anti emetics given with chemotherapy

Participants Receiving Fosaprepitant

Improvement in Nausea Score From Baseline to 2 Hours as Assessed by the Numerical Visual Analogue Scale

Improvement in Nausea Score From Baseline to 12 Hours

Change in Nausea Score From 2 Hours to 12 and 24 Hours

Improvement in Nausea Score From 2 Hours to 24 Hours

Number of participants who experienced vomiting episodes from baseline to 24 hours after receiving Fosaprepitant

Participants Who Recieved Fosaprepitant

Number of Participants Who Experienced Vomiting Episodes From Baseline to 24 Hours

This arm includes only those participants that required the use of second rescue drug after receiving Fosaprepitant

Participants That Received Fosaprepitant

Participants Who Required the Use of Second Rescue Drug (Time to Treatment Failure)

Number of participants achieving a Complete Response (CR) up to 24 hours after receiving fosaprepitant

Participants Achieving a Complete Response (no Emesis, no Additional Rescue Medication Required)

participants with self report fatigue or sedation after receiving fosaprepitant

Participants With Increased Fatigue or Sedation Within 24 Hours After Receiving Fosaprepitant

Only those in the study arm above that self report headache, dizziness, or pain/soreness at the infusion site are considered in this outcome

Participants With Specific Side Effects, Including Pain Sensation/Soreness at the Infusion Site, Headache, and Dizziness

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Acute Graft Versus Host Disease

Granisetron

Patients receive granisetron transdermal system patch 24-48 hrs before the initiation of chemotherapy. Patients wear the granisetron transdermal system patch for 7 days. Patients receive fosaprepitant dimeglumine IV over 15 minutes on day 1 of chemotherapy. Treatment repeats every 2 or 3 weeks for up to 4 courses in the absence of unacceptable toxicity.

Given granisetron transdermal system patch

granisetron transdermal system

laboratory biomarker analysis

Agustin Garcia

This clinical trial studies how well fosaprepitant dimeglumine and granisetron transdermal system work in preventing nausea and vomiting in patients with breast cancer undergoing chemotherapy. Antiemetic drugs may help lessen or prevent nausea and vomiting in patients treated with chemotherapy

PRIMARY OBJECTIVE:

I. To evaluate the efficacy of the combination of fosaprepitant (fosaprepitant dimeglumine) and granisetron transdermal system in the prevention of acute and delayed chemotherapy induced nausea and vomiting in breast cancer patients undergoing adjuvant or neoadjuvant chemotherapy.

SECONDARY OBJECTIVE:

I. To evaluate the safety of the combination of fosaprepitant and granisetron transdermal system in breast cancer patients undergoing adjuvan or neoadjuvant chemotherapy.

EXPLORATORY OBJECTIVE:

I. To explore the use of single nucleotide polymorphisms (SNPs) in the 5âhydroxytryptamine-3 (5HT3) and neurokinin-1 (NK-1) receptors as potential markers of efficacy.

OUTLINE: Patients receive granisetron transdermal system patch 24-48 hrs before the initiation of chemotherapy. Patients wear the granisetron transdermal system patch for 7 days. Patients receive fosaprepitant dimeglumine intravenously (IV) over 15 minutes on day 1 of chemotherapy. Treatment repeats every 2 or 3 weeks for up to 4 courses in the absence of unacceptable toxicity.

Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy

A Pilot Study to Evaluate the Efficacy of Fosaprepitant and Granisetron Transdermal System for the Prevention of Acute and Delayed Nausea and Vomiting in Breast Cancer Patients and to Identify Predictors of Response

The complete response rate with the exact 95% confidence intervals (CIs) will be calculated. The associations between the complete response rate and patient characteristics and biomarkers will be examined using Fisherâs exact test or Mann-Whitney U test whenever appropriate.

The complete response rate with the exact 95% CIs will be calculated. The associations between the complete response rate and patient characteristics and biomarkers will be examined using Fisherâs exact test or Mann-Whitney U test whenever appropriate.

University of Southern California

Digestive System Diseases

Neoplasm Metastasis

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Folfirinox

Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy.

Philip A. Philip, M.D., Ph.D., F.R.C.P

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.

Fosaprepitant Dimeglumine in Preventing Nausea and Vomiting in Patients With Gastrointestinal Cancer Receiving Combination Chemotherapy

Prevention of Nausea and Vomiting Secondary to FOLFIRINOX Chemotherapy in Gastrointestinal Cancer Patients

Achieved if a patient has no episodes of vomiting and requires no rescue medication during the first 120 hours after fosaprepitant dimeglumine administration.

Achieved if a patient has no episodes of vomiting at both 24 and 120 hours after fosaprepitant dimeglumine administration.

Achieved if a patient has no episodes of nausea at both 24 and 120 hours after fosaprepitant dimeglumine administration.

Philip Philip

Principal Investigator

All Participants

Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy.

fosaprepitant dimeglumine: Given IV

Treatment (Nausea and Vomiting Prophylaxis)

Race (NIH/OMB)

30 patients were eligible and consented to this protocol. 3 of these patients never began treatment, leaving our final analysis number at 27.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy of Two Antiemetic Regimens in Patients Receiving Radiotherapy and Concomitant Weekly Cisplatin	NCT01074697	Nausea Vomiting Genital Neoplas...	Fosaprepitant d... Placebo	18 Years -	Odense University Hospital
Rolapitant Hydrochloride in Preventing Nausea/Vomiting in Patients With Sarcoma Receiving Chemotherapy	NCT02732015	Locally Advance...	Dexamethasone Doxorubicin Fosaprepitant D... Ifosfamide Laboratory Biom... Mesna Ondansetron Questionnaire A... Rolapitant Hydr... Vincristine Sul...	18 Years - 65 Years	M.D. Anderson Cancer Center
Fosaprepitant Dimeglumine in Treating Patients With Nausea and Vomiting Caused By Chemotherapy	NCT01031953	Breakthrough Na... Unspecified Adu...	fosaprepitant d... systemic chemot... survey administ... quality-of-life...	18 Years - 120 Years	OHSU Knight Cancer Institute
Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy	NCT01649258	Breast Cancer Nausea Vomiting	granisetron tra... fosaprepitant d... laboratory biom...	18 Years -	University of Southern California
Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy	NCT01649258	Breast Cancer Nausea Vomiting	granisetron tra... fosaprepitant d... laboratory biom...	18 Years -	University of Southern California
Fosaprepitant Dimeglumine in Preventing Nausea and Vomiting in Patients With Gastrointestinal Cancer Receiving Combination Chemotherapy	NCT01504711	Gastrointestina... Nausea Post Che...	fosaprepitant d...	19 Years -	Barbara Ann Karmanos Cancer Institute
Fosaprepitant Dimeglumine, Palonosetron Hydrochloride, and Dexamethasone 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	NCT00895245	Nausea and Vomi... Stage III Squam... Stage III Squam... Stage III Squam... Stage III Squam... Stage III Squam... Stage IV Squamo... Stage IV Squamo... Stage IV Squamo... Stage IV Squamo... Stage IV Squamo...	fosaprepitant d... cisplatin palonosetron hy... dexamethasone Functional Livi... Emesis Diary Radiotherapy	18 Years - 70 Years	University of Washington

Spots Global Cancer Trial Database for fosaprepitant dimeglumine