CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Aprepitant +3 moredrug
Likely dose
Aprepitant 80 mg orally once daily on days 2 and 3; Cyclophosphamide 4 gm/m² I.V. over 90-120 minutesAI-extracted
Key inclusion· 5
  • ✓Undergoing autologous peripheral blood stem cell transplantation with cyclophosphamide-based mobilization
  • ✓Candidate for autologous PBSCT per institutional requirements
  • ✓SWOG performance status 0-2
  • ✓No nausea at baseline
Key exclusion· 7
  • ✕Psychiatric illness or multi-system organ failure
  • ✕Current illness requiring chronic systemic steroids or chronic antiemetics
  • ✕Gastrointestinal obstruction or active peptic ulcer disease
  • ✕Known hypersensitivity to any component of the study regimen

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00293384
NCT00293384N/ACompleted
CompareCT.gov

Pilot Study Evaluating Aprepitant (MK-869) for Prevention of Nausea & Vomiting Secondary to High Dose Cyclophosphamide Administered to Patients Underging Undergoing Peripheral Hematopoietic Progenitor Cell Mobilization Prior to Autologous Transplantation

Barbara Ann Karmanos Cancer Institute·interventional·Posted Feb 17, 2006·Updated Mar 15, 2016

In Brief

A clinical study evaluating Aprepitant, Cyclophosphamide, and 2 other interventions for Breast Cancer and 11 related conditions. Completed, enrolled 40 participants across 1 site.

Detailed Summary

RATIONALE: Antiemetic drugs, such as aprepitant, granisetron, and dexamethasone, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. PURPOSE: This clinical trial is studying how well giving aprepitant together with granisetron and dexamethasone works in preventing nausea and vomiting in patients receiving cyclophosphamide before undergoing an autologous stem cell transplant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Chronic Myeloproliferative Disorders, Gestational Trophoblastic Tumor, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms, Nausea and Vomiting, Neuroblastoma, Ovarian Cancer, Testicular Germ Cell Tumor
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 17, 2006
Enrollment StartOct 1, 2004
Primary CompletionJun 1, 2009
Study CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 20.4 years ago

Interventions

Aprepitantdrug

Aprepitant 80mg once daily in the morning on days 2 and 3

Cyclophosphamidedrug

Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes

Dexamethasonedrug

Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.

Granisetron hydrochloridedrug

Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration.