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

Completed · Phase 2

Conditions studied: Chemotherapy-Induced Nausea and Vomiting

In brief

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.

Key facts

Study ID

NCT01736917

Run by

Lawrence Einhorn

People needed

65

Starts

2013-01-01

Expected to finish

2015-06-01

Last updated by the study team

2016-05-25

Who can join

Age: 15 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• Siteman Cancer Center — St Louis, Missouri, United States
• Nebraska Cancer Specialists — Omaha, Nebraska, United States
• MUSC Hollings Cancer Center — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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