Phase II Study of Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone in Patients With Germ Cell Tumors Undergoing 5 Day Cisplatin-based Chemotherapy: Hoosier Oncology Group Study QL12-153
OUTLINE: This is a multi-center study.
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
- 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
- Bilirubin < 1.5 x ULN (upper limit of normal)
- Aspartate aminotransferase (AST, SGOT) ≤ 3 x ULN
- Alanine aminotransferase (ALT, SGPT) ≤ 3 x ULN
- Creatinine ≤ 2 mg/dl
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the Complete Response (CR) Rate of No Emetic Episodes or Use of Rescue Medications
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
Lawrence Einhorn, M.D.
Hoosier Oncology Group
United States: Institutional Review Board
|Indiana University Melvin and Bren Simon Cancer Center||Indianapolis, Indiana 46202-5289|
|Siteman Cancer Center||Saint Louis, Missouri 63110|
|MUSC Hollings Cancer Center||Charleston, South Carolina 29425|