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Trial record 7 of 14 for:    "Testicular Germ Cell Cancer" | "Hormones, Hormone Substitutes, and Hormone Antagonists"

Aprepitant in Preventing Nausea and Vomiting in Patients Who Are Undergoing a Stem Cell Transplant

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ClinicalTrials.gov Identifier: NCT00248547
Recruitment Status : Completed
First Posted : November 4, 2005
Results First Posted : December 21, 2011
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Joseph Bubalo, OHSU Knight Cancer Institute

Tracking Information
First Submitted Date  ICMJE November 3, 2005
First Posted Date  ICMJE November 4, 2005
Results First Submitted Date  ICMJE November 21, 2011
Results First Posted Date  ICMJE December 21, 2011
Last Update Posted Date May 9, 2017
Study Start Date  ICMJE May 2004
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2011)
Number of Emesis Free Participants During the Study Period. [ Time Frame: Up to three weeks ]
To compare the efficacy of aprepitant plus standard therapy to placebo plus standard therapy in control of nausea and vomiting during conditioning therapy for autologous or allogeneic hematopoietic stem cell transplantation (HSCT) as defined by the number of retch/emesis free days during the study period
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00248547 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2011)
  • Safety in Transplant Population [ Time Frame: Up to three weeks ]
    To assess the safety of aprepitant in the bone marrow transplant population
  • Effects on Nausea, Appetite and Taste Changes [ Time Frame: Up to three weeks ]
    To assess the effects of aprepitant on nausea, appetite, and taste changes, (via visual analogue scale [VAS]), nutritional intake, and mucositis in the bone marrow transplant population.
  • Pharmacokinetic Interaction [ Time Frame: Up to three weeks ]
    To assess the potential for aprepitant and cyclophosphamide to interact pharmacokinetically in a significant manner to change blood levels of aprepitant, cyclophosphamide, hydroxycyclophosphamide or CEPM.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aprepitant in Preventing Nausea and Vomiting in Patients Who Are Undergoing a Stem Cell Transplant
Official Title  ICMJE A Pilot Study of Aprepitant vs. Placebo Combined With Standard Antiemetics for the Control of Nausea and Vomiting During Hematopoietic Cell Transplatation(HCT)
Brief Summary

RATIONALE: Antiemetic drugs, such as aprepitant, ondansetron, and dexamethasone, may help lessen or prevent nausea and vomiting in patients undergoing a stem cell transplant.

PURPOSE: This randomized clinical trial is studying aprepitant, ondansetron, and dexamethasone to see how well they work compared to placebo, ondansetron, and dexamethasone in preventing nausea and vomiting in patients who are undergoing a stem cell transplant.

Detailed Description

OBJECTIVES:

Primary

  • Compare the efficacy of standard antiemetic therapy comprising ondansetron and dexamethasone combined with either aprepitant or placebo in controlling nausea and vomiting, as determined by the number of retch/emesis-free days, in patients undergoing hematopoietic stem cell transplantation.

Secondary

  • Determine the safety of aprepitant in these patients.
  • Compare nausea, appetite, taste changes, nutritional intake, and mucositis in patients treated with these regimens.
  • Determine the pharmacokinetics of cyclophosphamide, carboxyethylphosphoramide mustard, hydroxycyclophylamide, and aprepitant in these patients.

OUTLINE: This is a randomized, placebo-controlled, single-blind, pilot study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Beginning on the first day of conditioning chemotherapy, patients receive oral aprepitant once daily and standard antiemetic therapy comprising oral or IV ondansetron and oral dexamethasone.
  • Arm II: Patients receive oral placebo once daily and standard antiemetic therapy as in arm I.

In both arms, treatment continues until day 4 after stem cell transplant in the absence of unacceptable toxicity.

After completion of study therapy, patients are followed until day 18.

PROJECTED ACCRUAL: A total of 40 patients (20 per treatment arm) will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Cancer
Intervention  ICMJE
  • Drug: aprepitant
    Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
    Other Name: Emend
  • Drug: dexamethasone
    For Cyclophosphamide Total Body Irradiation(CyTBI) patients: Dexamethasone study drug 1 capsule PO daily, 1 hour prior to chemotherapy with aprepitant on total body irradiation(TBI) and cyclophosphamide chemotherapy days; For Busulfan Cyclophosphamide(BuCy) patients: Dexamethasone 1 capsule orally once daily, discontinue after last dose of chemotherapy.
    Other Name: Decadron
  • Drug: ondansetron
    For CyTBI patients: Ondansetron 8 mg orally evert 12 hours, begin 1 hour prior to first TBI dose and discontinue after last dose; then Ondansetron 8 mg IV every 12 hours X 4 doses, begin 30 minutes prior to first cyclophosphamide chemotherapy; For BuCy patients: Ondansetron 8 mg orally every 6 hours, begin 1 hour prior to first busulfan dose and discontinue after last busulfan dose is given. then: Ondansetron 8 mg IV Q 12 hours X 4 doses, begin 30 minutes prior to first cyclophosphamide chemotherapy
    Other Name: Zofran
  • Drug: placebo
    Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
    Other Name: placebo, sugar pill
Study Arms  ICMJE
  • Active Comparator: Aprepitant
    Interventions:
    • Drug: aprepitant
    • Drug: dexamethasone
    • Drug: ondansetron
  • Placebo Comparator: sugar pill
    Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
    Interventions:
    • Drug: dexamethasone
    • Drug: ondansetron
    • Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2006)
40
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion:

  • 18 years of age or greater
  • must be scheduled for an autologous or allogeneic bone marrow or peripheral stem cell transplant
  • Eastern Cooperative Oncology Group(ECOG) performance status < or = 2
  • patients must have signed informed consent
  • must be able to swallow tablets and capsules
  • must be receiving a cyclophosphamide containing regimen.

Exclusion:

  • patient has known sensitivity to aprepitant, ondansetron, or dexamethasone
  • patient has received another investigational drug in the past 30 days
  • patient has had emesis or requires antiemetic agents in the 48 hours prior to beginning conditioning therapy
  • patient has taken neurokinin-1 antagonists for 14 days prior to enrollment
  • patient is pregnant, has a positive serum human chorionic gonadotropin(hCg) or is lactating
  • patient has serum creatinine level > or = 2*ULN
  • patient has severe hepatic insufficiency (Child-Pugh score >9)
  • patient drinks > 5 drinks/day for the last year
  • patient with concurrent illness requiring systemic corticosteroid use other than planned dexamethasone during conditioning therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00248547
Other Study ID Numbers  ICMJE CDR0000445452
OHSU-HEM-03074-L ( Other Identifier: OHSU Knight Cancer Institute )
OHSU-1057 ( Other Identifier: OHSU IRB )
MERCK-OHSU-HEM-03074-L ( Other Identifier: Merck )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joseph Bubalo, OHSU Knight Cancer Institute
Study Sponsor  ICMJE OHSU Knight Cancer Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joseph Bubalo, PharmD OHSU Knight Cancer Institute
PRS Account OHSU Knight Cancer Institute
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP