Aprepitant + a 5HT3 + Dexamethasone in Patients With Germ Cell Tumors

NCT00572572 | Completed Phase 3 Results DMC

• 1 other identifier: QL05-37
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 6

Brief Summary

Aprepitant is currently approved for prophylaxis of acute and delayed CINV for highly emetogenic chemotherapy regimens, including cisplatin; however, it has not yet been studied in multiple-day chemotherapy treatment programs. This study will compare the addition of aprepitant compared to placebo administered on days 3,4,5 of chemotherapy administration for acute CINV prophylaxis with standard antiemetic prophylaxis and days 6 and 7 for delayed CINV prophylaxis in a double-blind, randomized, crossover study design.

Conditions

Germ Cell Tumors

Outcome Measures

Primary Outcomes (1)

• Complete Response.

  Participants were followed for chemotherapy induced nausea and vomiting (CINV) through day 8 of cycle 2. Complete response is defined as no emetic episodes and no use of rescue medication.

  Participants were evaluated from start of treatment through day 8 of cycle 2.

Secondary Outcomes (5)

• Proportion of Patients With no Emesis During the Acute CINV Time Period (Cycle Days 1-5)

  Participants were evaluated from cycle days 1-5.

• Proportion of Patients With no Emesis During the Delayed CINV Time Period (Cycle Days 6-8)

  Participants were evaluated from cycle days 6-8.

• Visual Analouge (VAS) 100mm Scale Score

  Days 1-8

• MD Anderson Symptom Inventory Score

  Days 1-8

• Preferred Treatment Cycle

  2 months

Study Arms (2)

Arm A: Aprepitant, Then Placebo

EXPERIMENTAL

Participants first received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 1, then received matched placebo PO daily on days 3 through 7 during study cycle 2

Drug: Aprepitant; Drug: Placebo

Arm B: Placebo, Then Aprepitant

EXPERIMENTAL

Participants first received matched placebo PO daily on days 3 through 7 during study cycle 1, then received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 2

Drug: Aprepitant; Drug: Placebo

Interventions

Aprepitant DRUG

Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.

Arm A: Aprepitant, Then Placebo; Arm B: Placebo, Then Aprepitant

Placebo DRUG

Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2.

Arm A: Aprepitant, Then Placebo; Arm B: Placebo, Then Aprepitant

Eligibility Criteria

• Age: 15 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic, serologic or clinical evidence of germ cell tumor.
• Patients scheduled to receive a 5 day fractionated cisplatin-based combination chemotherapy on permitted regimens
• Prior chemotherapy is allowed. Patients will be stratified based on previous treatment.
• Male patients 15 years of age or older at time of registration.
• Patient will provide written informed consent and authorization to release personal health information.

You may not qualify if:

• No known history of anticipatory nausea or vomiting.
• No use of another antiemetic agent within 72 hours prior to beginning chemotherapy.
• No known central nervous system (CNS) metastasis.
• No known hypersensitivity to any component of study regimen.
• No concurrent participation in a clinical trial which involves another investigational agent.
• No use of warfarin while on study.
• No use of agents expected to induce the metabolism of aprepitant which include: Rifampin, Rifabutin, Phenytoin, Carbamazepine, and barbiturates.
• No use of agents which may impair metabolism of aprepitant which include: Cisapride, macrolide antibiotics (Erythromycin, Clarithromycin, Azithromycin), azole antifungal agents (Ketoconazole, Itraconazole, Voriconazole, Fluconazole), Amifostine, Nelfinavir and Ritonavir.

Sponsors & Collaborators

• Hoosier Cancer Research Network: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (6)

Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Medical Consultants, P.C.

Muncie, Indiana, 47303, United States

Location

Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Froedtert/Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• Albany C, Brames MJ, Fausel C, Johnson CS, Picus J, Einhorn LH. Randomized, double-blind, placebo-controlled, phase III cross-over study evaluating the oral neurokinin-1 antagonist aprepitant in combination with a 5HT3 receptor antagonist and dexamethasone in patients with germ cell tumors receiving 5-day cisplatin combination chemotherapy regimens: a hoosier oncology group study. J Clin Oncol. 2012 Nov 10;30(32):3998-4003. doi: 10.1200/JCO.2011.39.5558. Epub 2012 Aug 20.

  PMID: 22915652 RESULT

Related Links

• Hoosier Oncology Group Home Page

MeSH Terms

Conditions

Neoplasms, Germ Cell and Embryonal

Interventions

Aprepitant

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Principal Investigator
• Organization: Hoosier Cancer Research Network

jsmith@hoosiercancer.org

317-921-2050

Study Officials

• Lawrence Einhorn, M.D.

  Hoosier Oncology Group, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2007
• First Posted: December 13, 2007
• Study Start: December 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: February 1, 2011
• Last Updated: April 6, 2016
• Results First Posted: April 6, 2016

Record last verified: 2016-03

Locations

US (6)