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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Hoosier Cancer Research Network
ClinicalTrials.gov Identifier:
NCT00572572
First received: December 11, 2007
Last updated: November 19, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Germ Cell Tumors
Drug: Aprepitant
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: Phase III, Double-Blind, Placebo-Controlled, Crossover Study Evaluating Aprepitant in Combination With a 5HT3 & Dexamethasone in Patients With Germ Cell Tumors Undergoing 5 Day Cisplatin-Based Chemotherapy Regimen

Resource links provided by NLM:


Further study details as provided by Hoosier Cancer Research Network:

Primary Outcome Measures:
  • To compare aprepitant with placebo in addition to standard antiemetic prophylaxis in preventing acute (days 1 through 5) and delayed (days 6 through 8) CINV measured by the proportion of patients with a Complete Response. [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare aprepitant with placebo in addition to standard antiemetic prophylaxis in preventing acute and delayed CINV measured by the proportion of patients with no emesis. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • To compare aprepitant with placebo in addition to standard antiemetic prophylaxis in preventing acute (days 1 through 5) and delayed (days 6 through 8) CINV measured by the proportion of patients with no nausea. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • To compare aprepitant with placebo in addition to standard antiemetic prophylaxis in preventing acute (days 1 through 5) and delayed (days 6 through 8) CINV measured by presence of symptoms measured by the MD Anderson Symptom Inventory. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • To compare aprepitant with placebo in addition to standard antiemetic prophylaxis in preventing acute and delayed CINV measured by the proportion of patients who state a preference for either aprepitant or placebo. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • To explore prevalence of polymorphisms of genes that encode for drug metabolizing enzymes, receptors, and drug transporters involved in the activity of anti-emetics used in the prophylaxis of CINV in patients with GCT. [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: December 2007
Study Completion Date: February 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A

Arm A, Study Cycle 1

Arm B, Study Cycle 2

Drug: Aprepitant

Aprepitant 125mg PO day 3 then 80mg on days 4 through 7

Subjects will be stratified prior to randomization based on previous administration of chemotherapy.

Subjects will randomize to aprepitant versus placebo with their first study cycle of chemotherapy and then cross over to opposite arm with the second study cycle.

Arm A, Study Cycle 1

Arm B, Study Cycle 2

Placebo Comparator: B

Arm A, Study Cycle 2

Arm B, Study Cycle 1

Drug: Placebo

Matched placebo PO daily on days 3 through 7

Subjects will be stratified prior to randomization based on previous administration of chemotherapy.

Subjects will randomize to aprepitant versus placebo with their first study cycle of chemotherapy and then cross over to opposite arm with the second study cycle.

Arm A, Study Cycle 2

Arm B, Study Cycle 1


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • No known history of anticipatory nausea or vomiting.
  • No use of another antiemetic agent within 72 hours prior to beginning chemotherapy.
  • No known 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.
  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: NCT00572572

Locations
United States, Indiana
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Medical Consultants, P.C.
Muncie, Indiana, United States, 47303
United States, Missouri
Siteman Cancer Center
St. Louis, Missouri, United States, 63110
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Wisconsin
Froedtert/Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Hoosier Cancer Research Network
Merck Sharp & Dohme Corp.
Investigators
Study Chair: Lawrence Einhorn, M.D. Hoosier Oncology Group, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Hoosier Cancer Research Network
ClinicalTrials.gov Identifier: NCT00572572     History of Changes
Other Study ID Numbers: QL05-37
Study First Received: December 11, 2007
Last Updated: November 19, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Dexamethasone acetate
Dexamethasone
Aprepitant
Fosaprepitant
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents

ClinicalTrials.gov processed this record on August 18, 2014