Effect of Aprepitant on Cyclophosphamide Pharmacokinetics in Patients With Breast Cancer

NCT00719173 | Completed Phase 1 DMC

• 5 other identifiers: LCCC 0514P30CA016086CDR0000600836UNC-05-2917UNC-GCRC-2411-ORC
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Antiemetic drugs, such as aprepitant, may help lessen or prevent nausea and vomiting in patients undergoing chemotherapy. PURPOSE: This randomized clinical trial is studying aprepitant to see how well it works compared to placebo in preventing nausea and vomiting in patients undergoing chemotherapy for breast cancer.

Conditions

Breast Cancer; Nausea and Vomiting

Keywords

nausea and vomiting; breast cancer

Outcome Measures

Primary Outcomes (1)

• Effect of aprepitant on cyclophosphamide and 4-hydroxycyclophosphamide pharmacokinetics as measured by plasma AUC

  Cyclophosphamide, 4-OH cyclophosphamide, and DCE PK with and without aprepitant

  05/2005 to 10/2010

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive aprepitant 125 mg orally once daily on day 1 and 80 mg orally once daily on days 2 and 3. Beginning 1 hour after receiving aprepitant, patients receive an infusion of cyclophosphamide on day 1. During course 2, patients crossover and receive treatment as in arm II.

Drug: aprepitant; Drug: cyclophosphamide; Other: placebo

Arm II

EXPERIMENTAL

Patients receive a placebo 125 mg orally once daily on day 1 and 80 mg orally once daily on days 2 and 3. Beginning 1 hour after receiving the placebo, patients will receive an infusion of cyclophosphamide infusion on day 1. During course 2, patients crossover and receive treatment as in arm I.

Drug: aprepitant; Drug: cyclophosphamide; Other: placebo

Interventions

aprepitant DRUG

Given orally

Arm I; Arm II

cyclophosphamide DRUG

Given IV

Arm I; Arm II

placebo OTHER

Given orally

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of breast cancer * Planning to receive cyclophosphamide 600 mg/m²-1,000 mg/m² IV infusion * No cyclophosphamide dose change between courses 1 and 2 PATIENT CHARACTERISTICS: * Life expectancy ≥ 2 months * ANC ≥ 1,500/μL * Platelet count ≥ 100 x 10\^9/L * Hemoglobin ≥ 9.0 g/dL * Serum creatinine ≤ 1.5 mg/dL * AST/ALT ≤ 2 times upper limit of normal * Not pregnant or nursing * No contraindication to aprepitant PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No concurrent medications that are CYP3A4 substrates, inhibitors, and/or inducers, with the exception of the dexamethasone contained as part of the standard antiemetic regimen

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Related Publications (1)

• Walko CM, Combest AJ, Spasojevic I, Yu AY, Bhushan S, Hull JH, Hoskins J, Armstrong D, Carey L, Collicio F, Dees EC. The effect of aprepitant and race on the pharmacokinetics of cyclophosphamide in breast cancer patients. Cancer Chemother Pharmacol. 2012 May;69(5):1189-96. doi: 10.1007/s00280-011-1815-5. Epub 2012 Jan 15.

  PMID: 22245954 DERIVED

Related Links

• Clinical trials at UNC Lineberger

MeSH Terms

Conditions

Breast Neoplasms; Nausea; Vomiting

Interventions

Aprepitant; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Christine M. Walko, PharmD, BCOP

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2008
• First Posted: July 21, 2008
• Study Start: August 1, 2005
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 4, 2024

Record last verified: 2017-02

Locations

US (1)