Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone in Germ Cell Tumors
Condition: Chemotherapy-Induced Nausea and Vomiting
MeSH terms: Neoplasms, Germ Cell and Embryonal; Vomiting
Intervention: Fosaprepitant; Dexamethasone; 5HT3
Intervention description: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophylaxis; Dexamethasone 20mg PO daily on D1 and 2 for acute prophylaxis Dexamethasone 4mg PO BID on Days 6 through 8; Any 5HT3RA on D1-5; D1, 3 and 5 if palonosetron is used.
Intervention MeSH terms: Dexamethasone; Fosaprepitant; Aprepitant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: Male
Minimum age: 15 Years
Healthy volunteers: No
Keywords: Fosaprepitant; 5HT3 Receptor Antagonists; Dexamethasone; Germ Cell Tumors; Testis Cancer; Rescue Medications

Summary:

      The hypothesis is that the substitution of multi-day oral aprepitant with (intravenous) IV
      fosaprepitant, in combination with a 5-HT3 receptor antagonists (5HT3RA) + dexamethasone will
      provide comparable protection from 5 day cisplatin chemotherapy induced nausea and vomiting,
      compared to the results of our prior study of aprepitant. This study will be the first
      clinical trial evaluating fosaprepitant in patients receiving multi-day cisplatin. This will
      be a single arm, phase II study. The investigators propose to utilize intravenous (IV)
      fosaprepitant on days 3 and 5 of the 5-day cisplatin chemotherapy regimen. It is anticipated
      that fosaprepitant can suppress delayed chemo-induced nausea and vomiting for 2-5 days after
      therapy. This study will test the value of fosaprepitant in this patient population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male patients ≥15 years of age with histologically or cytologically confirmed
             diagnosis of germ cell tumor receiving a standard 5 day cisplatin based chemotherapy
             regimen. Prior chemotherapy is allowed. Patients do not have to be chemo naïve.

          -  Written informed consent and HIPAA authorization for release of personal health
             information.

          -  Patients must have had no nausea or vomiting for 24 hours and no anti-emetic use for
             72 hours prior to starting protocol therapy. Treatment must not start in registered
             patients until this criteria is met.

        Exclusion Criteria:

          -  No active central nervous system (CNS) metastases. Patients with neurological symptoms
             must undergo a head CT scan or brain MRI to exclude brain metastasis. NOTE: A patient
             with prior brain metastasis may be considered if they have completed their treatment
             for brain metastasis, no longer require corticosteroids, and are asymptomatic.

          -  No prior malignancy is allowed except for adequately treated basal cell or squamous
             cell skin cancer, in situ cervical cancer, Gleason < grade 7 prostate cancers, or
             other cancer for which the patient has been disease-free for at least 1 year.

          -  No previous treatment with any investigational agent within 30 days prior to
             registration for protocol therapy.

          -  No concurrent participation in a clinical trial which involves another investigational
             agent.

          -  No use of agents expected to induce the metabolism of fosaprepitant which include:
             rifampin, rifabutin, phenytoin, carbamazepine, and barbiturates.

          -  No concurrent use of agents which may inhibit metabolism of fosaprepitant which
             include: cisapride, macrolide antibiotics (erythromycin, clarithromycin,
             azithromycin), azole antifungal agents (ketoconazole, itraconazole, voriconazole,
             fluconazole), amifostine, nelfinavir, calcium channel antagonists such as verapamil
             and diltiazem, and ritonavir.

          -  No concurrent use of warfarin while on study.

          -  No known history of anticipatory nausea or vomiting.

          -  No clinically significant infections as judged by the treating investigator.