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
15 Years
N/A
Male
Chemotherapy-Induced Nausea and Vomiting
Trial Information
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.
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
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine the Complete Response (CR) Rate of No Emetic Episodes or Use of Rescue Medications
Outcome Description:
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
Outcome Time Frame:
1 month
Safety Issue:
No
Principal Investigator
Lawrence Einhorn, M.D.
Investigator Role:
Study Chair
Investigator Affiliation:
Hoosier Oncology Group
Authority:
United States: Institutional Review Board
Study ID:
QL12-153
NCT ID:
NCT01736917
Start Date:
January 2013
Completion Date:
January 2015
Related Keywords:
- Chemotherapy-Induced Nausea and Vomiting
- Fosaprepitant
- 5HT3 Receptor Antagonists
- Dexamethasone
- Germ Cell Tumors
- Testis Cancer
- Rescue Medications
- Vomiting
- Neoplasms, Germ Cell and Embryonal
Name | Location |
|---|---|
| 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 |
