Fosaprepitant Dimeglumine, Palonosetron Hydrochloride, and Dexamethasone in Preventing Nausea and Vomiting Caused by Cisplatin in Patients With Stage III or Stage IV Head and Neck Cancer Undergoing Chemotherapy and Radiation Therapy
Condition: Nausea and Vomiting; Stage III Squamous Cell Carcinoma of the Hypopharynx; Stage III Squamous Cell Carcinoma of the Larynx; Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage III Squamous Cell Carcinoma of the Nasopharynx; Stage III Squamous Cell Carcinoma of the Oropharynx; Stage IV Squamous Cell Carcinoma of the Hypopharynx; Stage IV Squamous Cell Carcinoma of the Larynx; Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IV Squamous Cell Carcinoma of the Nasopharynx; Stage IV Squamous Cell Carcinoma of the Oropharynx
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Laryngeal Neoplasms; Oropharyngeal Neoplasms; Squamous Cell Carcinoma of Head and Neck; Nasopharyngeal Carcinoma; Laryngeal Diseases; Nausea; Vomiting
Intervention: fosaprepitant dimeglumine; cisplatin; palonosetron hydrochloride; dexamethasone; Functional Living Index-Emesis Questionnaire; Emesis Diary; Radiotherapy
Intervention description: Given IV; Given IV; Given IV; Given IV and orally; Ancillary studies; Ancillary studies; Undergo radiotherapy
Intervention MeSH terms: Dexamethasone; Palonosetron; Fosaprepitant; Aprepitant
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      RATIONALE: Fosaprepitant dimeglumine, palonosetron hydrochloride, and dexamethasone may help
      lessen or prevent nausea and vomiting caused by cisplatin in patients with head and neck
      cancer undergoing chemotherapy and radiation therapy.

      PURPOSE: This phase II trial is studying how well fosaprepitant dimeglumine together with
      palonosetron hydrochloride and dexamethasone works in preventing nausea and vomiting caused
      by cisplatin in patients with stage III or stage IV head and neck cancer undergoing
      chemotherapy and radiation therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cytologically or pathologically documented squamous cell carcinoma of the oral cavity,
             oropharynx, larynx, hypopharynx, or nasopharynx

          -  Stage III or IV disease according to the AJCC Cancer Staging Handbook Sixth Edition

          -  Planned definitive or adjuvant radiation with concurrent cisplatin (100 mg/m2 every 3
             weeks for three cycles)

          -  ECOG Performance Status of 0-2

          -  Adequate Organ Function (Hepatic: bilirubin =< 1.5 x ULN; AST and ALT =< 3 x ULN;
             Renal: calculated creatinine clearance >= 55ml/min (using the Cockcroft-Gault
             Formula); Bone Marrow: platelet count >= 100 x 10^9/L; absolute neutrophil count >=
             1.25 x 10^9/L)

          -  Signed Informed Consent

          -  Male and female patients with reproductive potential must use an acceptable
             contraceptive method (with double barrier protection for pre-menopausal women)

          -  Predicted life expectancy > 12 weeks

          -  Willingness to complete patient diary and questionnaires

        Exclusion Criteria:

          -  Inability or unwillingness to comply with radiotherapy or chemotherapy

          -  Use of illicit drugs or on-going alcohol use

          -  Vomiting within the 24 hours prior to cisplatin infusion

          -  Evidence of clinically significant congestive heart failure (Patients must be able to
             tolerate hydration with cisplatin)

          -  Peripheral Neuropathy > Grade 2

          -  Significant hearing loss

          -  Pregnant or breast-feeding women

          -  Patients may be enrolled in additional clinical trials, as long as no additional
             investigational agents are being used

          -  Patients with a hypersensitivity to fosaprepitant, aprepitant, polysorbate, and any
             other components of the EMEND product

          -  The following therapies are excluded during the treatment phase of the study:
             investigational agents; anti-neoplastic or anti-tumor agents, including immunotherapy,
             and hormonal anti-cancer therapy; additional scheduled anti-emetic medications, unless
             needed as rescue medications for acute or delayed nausea/vomiting

          -  Strong Inhibitors of CYP3A4: ketoconazole, itraconazole, clarithromycin, ritonavir,
             and nelfinavir; strong Inducers of CYP3A4: rifampin, carbamazepine, and phenytoin