Pharmacokinetic Study on the Addition of Aprepitant to Cisplatin - Etoposide Treatment in Lung Cancer Patients

NCT00588835 | Terminated Phase 4

• 2 other identifiers: UMCN-AKF 07.02EudraCTnr 2007-003347-73
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine whether aprepitant can be used in the Cisplatin - Etoposide chemotherapeutic regimen.

Conditions

Tumor

Keywords

pharmacokinetics; nausea and vomiting post chemotherapy

Outcome Measures

Primary Outcomes (1)

• plasma concentrations of etoposide will be measured

  just before etoposide infusion, at 0.5, 1,4,6,8 and 24 hours and 32 hours after dosing on study days 1 and 3

Secondary Outcomes (1)

• Nausea and emetic episodes are recorded

  Day 1,3,5 and 8 of each cycle

Study Arms (2)

A

EXPERIMENTAL

Aprepitant 125mg oral on day 1 and 80mg on day 2 and 3 during CE treatment.

Drug: aprepitant

B

ACTIVE COMPARATOR

CE cycle with standard anti-emetic regimen.

Drug: Dexamethasone and Ondansetron during CE-treatment

Interventions

aprepitant DRUG

125mg on Day 1; 80mg on Day 2-3 during CE cycle. Dexamethasone is added as well.

Also known as: Emend

A

Dexamethasone and Ondansetron during CE-treatment DRUG

Standard anti-emetic regimen during CE treatment

Also known as: Decadron, Zofran

B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between 18 and 75 years of age
• able and willing to sign informed consent form
• indication for treatment with CE regimen
• subject is expected to receive at least 2 cycles of CE regimen
• able to swallow capsules

You may not qualify if:

• history of sensitivity/idiosyncrasy to aprepitant or excipients
• condition that might interfere with drug absorption, distribution metabolism or excretion.
• history or current abuse of drugs, alcohol or solvents
• inability to understand the nature and extent of the trial and procedures
• participation in a drug trial within 30 days prior to the first dose
• febrile illness within 3 days before the first dose
• concomitant use of agents that are known to interfere with aprepitant pharmacokinetics
• abnormal liver or renal function

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

University Medical Center Groningen

Groningen, Netherlands

Location

Radboud University Nijmegen Medical Centre

Nijmegen, Netherlands

Location

MeSH Terms

Conditions

Neoplasms; Nausea

Interventions

Aprepitant; Dexamethasone; Calcium Dobesilate; Ondansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Imidazoles; Azoles; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• David M. Burger, PharmD PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 24, 2007
• First Posted: January 9, 2008
• Study Start: March 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: November 30, 2020

Record last verified: 2020-11

Locations

NL (2)