- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01640340
Ondansetron Versus Palonosetron Antiemetic Regimen Prior to Highly Emetogenic Chemotherapy(HEC)
Pilot Study on the Efficacy of an Ondansetron Versus Palonosetron-containing Antiemetic Regimen Prior to Highly Emetogenic Chemotherapy(HEC).
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
PRIMARY OBJECTIVES:
I. The goal of this study is to evaluate the overall complete response rate (CR, no emesis and no use of rescue medication from 0 to 120 hours after chemotherapy) of two different antiemetic regimens (palonosetron + aprepitant + dexamethasone and ondansetron + aprepitant + dexamethasone) for patients undergoing the first cycle of highly emetogenic chemotherapy (HEC).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive palonosetron hydrochloride intravenously (IV) 30 minutes prior to chemotherapy on day 1, aprepitant orally (PO) 60 minutes prior to chemotherapy on days 1-3, and dexamethasone PO 30 minutes prior to chemotherapy on days 1-4.
ARM II: Patients receive ondansetron PO 30 minutes prior to chemotherapy on day 1 and aprepitant and dexamethasone as in Arm I.
After completion of study treatment, patients are followed up for 7 days.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Ohio
-
Columbus, Ohio, Förenta staterna, 43210
- Ohio State University Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Confirmed malignancy
- Chemotherapy naive or treated with only low or minimally emetogenic chemotherapy in the past (as defined by the National Comprehensive Cancer Network version [v].2.201 Antiemetic Guidelines)
- Scheduled to receive the first dose of their first cycle of HEC
- Patients receiving multi-day chemotherapy, the HEC portion must be on day 1 and the remaining days of chemotherapy must be minimally emetogenic (i.e. fluorouracil)
- Performance status of Eastern Cooperative Oncology Group (ECOG) grade 0-2
- Able to provide informed consent
- Able to read and write in English or have someone that can that can translate to them and record their diary entries
- Able to take oral medications
Patients are allowed to participate in a concurrent clinical trial, if the other trial:
- Does not mandate an antiemetic regimen that interferes with this study
- Allows antiemetic administration at the physician's discretion
- Does not prohibit the patient from participating in this study
- Patients must be willing to participate with daily diary entries for 5 days following chemotherapy, and agree to have a 5 minute follow-up call on day 2 or 3 and day 5, 6 or 7
Exclusion Criteria:
- Has stage IV (metastatic) disease
- Known hypersensitivity to ondansetron, palonosetron, aprepitant, or dexamethasone
- Have received or will receive agents that are strong cytochrome P450 3A4 (CYP450 3A4) inducers and/or inhibitors and known to cause clinically relevant drug interactions within one week prior to study treatment and continuing through day 5; any vomiting or retching within 24 hours before administration of chemotherapy
- Grade 2 nausea or greater, according to the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v 4.0) within 24 hours before administration of chemotherapy
- Received an antiemetic within 24 hours before study drug administration, excluding the use of benzodiazepines
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2.5 times upper limit of normal
- Total bilirubin > 1.5 times upper limit of normal
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Arm I (palonosetron hydrochloride)
Patients receive palonosetron hydrochloride IV 30 minutes prior to chemotherapy on day 1, aprepitant PO (by mouth) 60 minutes prior to chemotherapy on days 1-3, and dexamethasone PO 30 minutes prior to chemotherapy on days 1-4.
|
Givet PO
Andra namn:
Given by mouth
Andra namn:
Given IV(intervenous infusion)
Andra namn:
|
Experimentell: Arm II (ondansetron)
Patients receive ondansetron PO 30 minutes prior to chemotherapy on day 1 and aprepitant and dexamethasone as in Arm I.
|
Givet PO
Andra namn:
Given by mouth
Andra namn:
Given PO
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Overall CR(Complete Response)After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication
Tidsram: Up to 120 hours after completion of chemotherapy
|
We will use exact binomial methods to estimate proportions and their associated 95% confidence intervals.
|
Up to 120 hours after completion of chemotherapy
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Acute CR (Complete Response)
Tidsram: 0-24 hours after chemotherapy
|
After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication from time 0 to 24 hours.
|
0-24 hours after chemotherapy
|
Delayed CR (Complete Response)
Tidsram: 24-120 hours after chemotherapy
|
After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication From Time 24to 120 Hours.
|
24-120 hours after chemotherapy
|
Percentage of Patients Who Experienced Grade 1, 2 or 3 Nausea From Time 0 to 120 Hours
Tidsram: Time 0 to 120 hours
|
The percentage of patients who experienced grade 1, 2 or 3 nausea from time 0 to 120 hours.
Nausea graded using the National Cancer Institute (NCI) CTCAE (Common Toxicity Criteria for Adverse Effects)version 4.0 Nausea Grading Scale.
Grade 1=Loss of appetite without alteration in eating habits, Grade 2= Oral intake decreased without significant weight loss, dehydration or malnutrition, Grade 3= Inadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated.
|
Time 0 to 120 hours
|
Visual Analog Scale (VAS) Scores
Tidsram: Up to 7 days after completion of study treatment
|
Up to 7 days after completion of study treatment
|
|
Use of Rescue Medication for Each Treatment Arm
Tidsram: From time 0 to 120 hours
|
From time 0 to 120 hours
|
|
Percentage of Patients Who Experienced Grade 1, 2 or 3 Vomiting From Time 0 to 120 Hours
Tidsram: From time 0 to 120 hours
|
The percentage of patients who experienced grade 1, 2 or 3 vomiting from time 0 to 120 hours.
Nausea graded using the National Cancer Institute (NCI) CTCAE v 4.0 vomiting Grading Scale.
Grade 1=Loss of appetite without alteration in eating habits, Grade 2= Oral intake decreased without significant weight loss, dehydration or malnutrition, Grade 3= Inadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated.
|
From time 0 to 120 hours
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Rachel Layman, Ohio State University
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neoplasmer
- Läkemedels fysiologiska effekter
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Depressiva medel i centrala nervsystemet
- Autonoma agenter
- Agenter från det perifera nervsystemet
- Antiinflammatoriska medel
- Antineoplastiska medel
- Antiemetika
- Gastrointestinala medel
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitut och hormonantagonister
- Antineoplastiska medel, hormonella
- Dermatologiska medel
- Antipsykotiska medel
- Lugnande medel
- Psykotropa droger
- Serotoninmedel
- Serotoninantagonister
- Anti-ångest medel
- Serotonin 5-HT3-receptorantagonister
- Antiklåda
- Neurokinin-1-receptorantagonister
- Dexametason
- Palonosetron
- Ondansetron
- Aprepitant
Andra studie-ID-nummer
- OSU-10118
- NCI-2012-01009 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
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