Aprepitant, Granisetron, & Dexamethasone in Preventing Nausea & Vomiting in Pts. Receiving Cyclophosphamide Before a Stem Cell Transplant

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00293384
• Other study ID #: CDR0000456201
• Secondary ID: P30CA022453WSU-D
• Status: Completed
• Phase: N/A
• First received: February 16, 2006
• Last updated: February 12, 2016
• Start date: October 2004
• Est. completion date: February 2012

Study information

• Verified date: February 2016
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

Primary

• Evaluate the efficacy of the addition of aprepitant in controlling acute vomiting with the standard prophylactic anti-emetic combination of granisetron hydrochloride and dexamethasone in patients receiving therapy comprising high-dose cyclophosphamide to mobilize stem cells prior to leukapheresis for autologous stem cell transplantation.

Secondary

• Evaluate the efficacy of the addition of aprepitant in controlling delayed vomiting in these patients.

• Evaluate the efficacy of the addition of aprepitant in controlling overall nausea in these patients.

• Identify side effects of the addition of aprepitant to this regimen in these patients.

OUTLINE: Patients receive granisetron hydrochloride orally or IV and oral dexamethasone, followed 1 hour later by cyclophosphamide IV over 2 hours on day 1. Patients also receive oral aprepitant once daily on days 1-3. Treatment continues in absence of unacceptable toxicity.

After completion of study treatment, patients are followed for 30 days.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2012
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Undergoing autologous peripheral blood stem cell transplantation and stem cell mobilization using cyclophosphamide

• Candidate (per institutional requirements) for autologous peripheral blood stem cell transplantation

• No psychiatric illness or multi-system organ failure

• No nausea at baseline

PATIENT CHARACTERISTICS:

• SWOG performance status 0-2

• Fewer than 5 alcoholic drinks per day within the past year

• No current illness requiring chronic systemic steroids or requirement for chronic use of anti-emetics

• No gastrointestinal obstruction or active peptic ulcer disease

• AST and ALT = 3 times upper limit of normal (ULN)

• Bilirubin = 3 times ULN

• Alkaline phosphatase = 3 times ULN

• Creatinine = 2 mg/dL

• No known hypersensitivity to any component of the study regimen

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier contraception

• No unrelenting hiccups

PRIOR CONCURRENT THERAPY:

• No chronic therapeutic warfarin > 1 mg dose per day

• No other concurrent investigational agents

• No concurrent oral contraceptives (except for stopping menses), tolbutamide, phenytoin, midazolam, ketoconazole, rifampin, paroxetine hydrochloride, or diltiazem hydrochloride

• No concurrent illegal drugs

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Chronic Myeloproliferative Disorders
• Gestational Trophoblastic Disease
• Gestational Trophoblastic Tumor
• Leukemia
• Lymphoma
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Neoplasms
• Myeloproliferative Disorders
• Nausea
• Nausea and Vomiting
• Neoplasms
• Neoplasms, Germ Cell and Embryonal
• Neoplasms, Plasma Cell
• Neuroblastoma
• Ovarian Cancer
• Plasmacytoma
• Preleukemia
• Testicular Germ Cell Tumor
• Testicular Neoplasms
• Trophoblastic Neoplasms
• Vomiting

Intervention

Drug:
• Aprepitant
Aprepitant 80mg once daily in the morning on days 2 and 3
• Cyclophosphamide
Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes
• Dexamethasone
Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.
• Granisetron hydrochloride
Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration.

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall Nausea Controlled		at 0-120 hours	Yes
Primary	Proportion of Participants With Controlled Acute Vomiting	No episodes of vomiting and no rescue medication during first 24 hours after cyclophosphamide administration.	at 0-24 hours	Yes
Secondary	Delayed Vomiting Controlled		at 25-120 hours	Yes
Secondary	Toxicity Grade 3, 4, or 5		at 0-120 hours	Yes