Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone in Germ Cell Tumors

• Determine the Complete Response (CR) Rate of No Emetic Episodes or Use of Rescue Medications [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  This will determine the Complete Response (CR) rate (no emetic episodes or use of rescue medications) in germ cell tumor patients treated with IV fosaprepitant in combination with a 5HT3RA plus dexamethasone during a 5 day cisplatin regimen
  
  

• Measure the Incidence of Vomiting or Retching [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  This will measure the incidence of vomiting or retching via patient log Days 1-8.
  
  
• Describe Detailed Use of Rescue Medications. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  This will describe the detailed use of rescue medications for patients via patient log.
  
  
• Describe the Patient's Self-Reported Assessment of Nausea [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  This will describe the patient's self-reported assessment of nausea Days 1-8 using a 0-100mm visual analog scale (VAS).
  
  
• Determine the Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  This will determine the safety and toxicity of the treatment regimen utilizing CTCAE V4.0
  
  

OUTLINE: This is a multi-center study.

Treatment Regimen:

Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.

Any germ cell chemotherapy regimen utilizing cisplatin (20mg/m2 x 5 days). This will usually be combined with bleomycin (BEP), etoposide (EP), ifosfamide (VIP), vinblastine (VeIP), paclitaxel (TIP) or epirubicin. All of these regimens get the identical cisplatin, which is the only highly emetic drug in any of the chemo regimens.

Acute emesis prophylaxis (administered per institutional standards prior to chemotherapy):

• Any 5HT3 receptor antagonist may be used days 1 through 5 or days 1, 3 and 5 if palonosetron is used per institutional standards.
• Dexamethasone 20mg PO (orally) daily, days 1 and 2
• Fosaprepitant 150mg IV on day 3

Delayed emesis prophylaxis:

• Fosaprepitant 150mg IV on day 5
• Dexamethasone 4mg PO BID (twice a day) on days 6, 7 and 8

PRN (as needed) antiemetics allowed at the discretion of the treating investigator

• No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods

ECOG Performance Status of 0-2

Life Expectancy: Not specified

Hematopoietic:

• White blood cell count (WBC) > 3.0 K/mm3
• Absolute neutrophil count ≥ 1.5 K/mm3
• Hemoglobin (Hgb) > 10 g/dL
• Platelets > 100 K/mm3

Hepatic:

• Bilirubin < 1.5 x ULN (upper limit of normal)
• Aspartate aminotransferase (AST, SGOT) ≤ 3 x ULN
• Alanine aminotransferase (ALT, SGPT) ≤ 3 x ULN

Renal:

• Creatinine ≤ 2 mg/dl