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Effect of Aprepitant on Cyclophosphamide Pharmacokinetics in Patients With Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00719173
First received: July 18, 2008
Last updated: May 17, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Breast Cancer
Nausea and Vomiting
Drug: aprepitant
Drug: cyclophosphamide
Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating the Effect of Aprepitant on Cyclophosphamide Pharmacokinetics

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Effect of aprepitant on cyclophosphamide and 4-hydroxycyclophosphamide pharmacokinetics as measured by plasma AUC [ Time Frame: 05/2005 to 10/2010 ] [ Designated as safety issue: No ]
    Cyclophosphamide, 4-OH cyclophosphamide, and DCE PK with and without aprepitant


Enrollment: 19
Study Start Date: August 2005
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
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
Given orally
Drug: cyclophosphamide
Given IV
Other: placebo
Given orally
Experimental: Arm II
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
Given orally
Drug: cyclophosphamide
Given IV
Other: placebo
Given orally

Detailed Description:

OBJECTIVES:

Primary

  • To evaluate the effect of aprepitant on cyclophosphamide and 4-hydroxycyclophosphamide pharmacokinetics as measured by plasma AUC in patients with breast cancer.

Secondary

  • To evaluate total control of nausea and vomiting, as defined by no vomiting episodes and no use of rescue medication, 72 hours after courses 1 and 2 of chemotherapy.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

  • Arm I: 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 (placebo) as in arm II.
  • Arm II: 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 (aprepitant) as in arm I.

Patients complete a diary documenting nausea and vomiting on days 1, 2, and 3 of both courses. Patients also complete The Functional Living Index-Emesis (FLIE) questionnaire documenting compliance, rescue antiemetic therapy, and any adverse effects and record them in the diary for each course. Information in the patient's diary is obtained by the coordinator via telephone on day 4 of each course.

Patients undergo blood sample collection periodically for pharmacokinetic studies via high performance liquid chromatography.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719173

Locations
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
Principal Investigator: Christine M. Walko, PharmD, BCOP UNC Lineberger Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided by UNC Lineberger Comprehensive Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00719173     History of Changes
Other Study ID Numbers: LCCC 0514, P30CA016086, CDR0000600836, UNC-05-2917, UNC-GCRC-2411-ORC
Study First Received: July 18, 2008
Last Updated: May 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
nausea and vomiting
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Vomiting
Breast Diseases
Neoplasms
Neoplasms by Site
Signs and Symptoms
Signs and Symptoms, Digestive
Skin Diseases
Aprepitant
Cyclophosphamide
Fosaprepitant
Alkylating Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014