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

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Brief Title

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

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

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.
    

Detailed Description

      OUTLINE: This is a multi-center trial.

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

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

      Cisplatin-based regimen for germ cell tumors containing 20mg/m2/day IV days 1 through 5,
      first day of chemotherapy administration is day 1. Permitted treatment regimens:

      Regimen 1 (BEP) Cisplatin (20mg/m2/day) IV on days 1 to 5 Etoposide (100 mg/m2/day) IV on
      days 1 to 5 Bleomycin 30 U/IV on days 1, 8, 15

      Regimen 2 (EP) Cisplatin (20mg/m2/day) IV on days 1 to 5 Etoposide (100 mg/m2/day) IV on days
      1 to 5

      Regimen 3 (VIP) Cisplatin (20mg/m2/day) IV on days 1 to 5 Ifosfamide (1200 mg/m2/day) IV on
      days 1 to 5 (with mesna uroprophylaxis at 100% ifosfamide dosing) Etoposide (75 mg/m2/day) IV
      on days 1 to 5

      Regimen 4 (VeIP) Cisplatin (20mg/m2/day) IV on days 1 to 5 Ifosfamide (1200 mg/m2/day) IV on
      days 1 to 5 (with mesna uroprophylaxis at 100% ifosfamide dosing) Vinblastine (0.11
      mg/kg/day) IV on days 1 and 2

      Regimen 5 (EC) Cisplatin (20mg/m2/day) IV on days 1 to 5 Epirubicin (90 mg/m2/day) IV on day
      1

      Patients are treated on study for two cycles. At the completion of protocol therapy patients
      will receive additional chemotherapy at the discretion of the treating investigator.

      If a patient requires discontinuation of one medication or more on a regimen, the patient
      must be discontinued from the study.

      Performance Status:

        -  Not specified

      Hematopoietic:

        -  Not specified

      Hepatic:

        -  Bilirubin < 3 x upper limit of normal

        -  Aspartate aminotransferase (AST, SGOT) < 3 x upper limit of normal

        -  Alanine aminotransferase (ALT, SGPT) < 3 x upper limit of normal

        -  Alk Phos < 3 x upper limit of normal

      Renal:

        -  Serum Creatinine <2 mg/dL

      Pulmonary:

        -  Not specified
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Complete Response.

Secondary Outcome

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

Condition

Germ Cell Tumors

Intervention

Aprepitant

Study Arms / Comparison Groups

 Arm A: Aprepitant, Then Placebo
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

69

Start Date

December 2007

Completion Date

February 2011

Primary Completion Date

December 2010

Eligibility 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 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.
      

Gender

Male

Ages

15 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Lawrence Einhorn, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00572572

Organization ID

QL05-37


Responsible Party

Sponsor

Study Sponsor

Hoosier Cancer Research Network

Collaborators

 Merck Sharp & Dohme Corp.

Study Sponsor

Lawrence Einhorn, M.D., Study Chair, Hoosier Oncology Group, Inc.


Verification Date

March 2016