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

NCT ID: NCT00293384

Last Updated: 2016-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2012-02-29

Brief 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.

Detailed 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.

Conditions

Breast 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Aprepitant, Dexamethasone, Cytoxan & Kytril

Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.

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

Days 2 & 3: Aprepitant 80 mg once daily in the morning.

Group Type: EXPERIMENTAL

Aprepitant

Intervention Type: DRUG

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

Cyclophosphamide

Intervention Type: DRUG

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

Dexamethasone

Intervention Type: DRUG

Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.

Granisetron hydrochloride

Intervention Type: DRUG

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

Interventions

Aprepitant

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

Intervention Type: DRUG

Cyclophosphamide

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

Intervention Type: DRUG

Dexamethasone

Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.

Intervention Type: DRUG

Granisetron hydrochloride

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

Intervention Type: DRUG

Other Intervention Names

Emend; Cytoxan®; Neosar®; Decadron; Diodex; Hexadrol; Maxidex; Dexamethasone Sodium Phosphate; Dexamethasone Acetate; KYTRIL®

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Barbara Ann Karmanos Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Muneer Abidi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muneer H. Abidi, MD

Role: STUDY_CHAIR

Barbara Ann Karmanos Cancer Institute

Locations

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Countries

United States

Other Identifiers

P30CA022453

Identifier Type: NIH

Identifier Source: secondary_id

View Link

WSU-D-2797

Identifier Type: OTHER

Identifier Source: secondary_id

WSU-0504001728

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000456201

Identifier Type: -

Identifier Source: org_study_id