Phase 3
N=69
Aprepitant + a 5HT3 + Dexamethasone in Patients With Germ Cell Tumors
Germ Cell Tumors
Bottom Line
View on ClinicalTrials.gov: NCT00572572 ↗Enrolled (actual)
69
Serious AEs
23.2%
Results posted
Apr 2016
Primary outcome: Primary: Complete Response. — 47; 15 percentage of evaluable subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aprepitant (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- Male
- Sponsor
- Hoosier Cancer Research Network
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response. |
47; 15 | — |
| SECONDARY Proportion of Patients With no Emesis During the Acute CINV Time Period (Cycle Days 1-5) |
80; 52 | — |
| SECONDARY Proportion of Patients With no Emesis During the Delayed CINV Time Period (Cycle Days 6-8) |
92; 78 | — |
| SECONDARY Visual Analouge (VAS) 100mm Scale Score |
22.6; 27.1 | — |
| SECONDARY MD Anderson Symptom Inventory Score |
3.2; 2.9 | — |
| SECONDARY Preferred Treatment Cycle |
78; 22 | — |
Summary
Aprepitant is currently approved for prophylaxis of acute and delayed CINV for highly emetogenic chemotherapy regimens, including cisplatin; however, it has not yet been studied in multiple-day chemotherapy treatment programs. This study will compare the addition of aprepitant compared to placebo administered on days 3,4,5 of chemotherapy administration for acute CINV prophylaxis with standard antiemetic prophylaxis and days 6 and 7 for delayed CINV prophylaxis in a double-blind, randomized, crossover study design.
Eligibility Criteria
Inclusion Criteria
- Histologic, serologic or clinical evidence of germ cell tumor.
- Patients scheduled to receive a 5 day fractionated cisplatin-based combination chemotherapy on permitted regimens
- Prior chemotherapy is allowed. Patients will be stratified based on previous treatment.
- Male patients 15 years of age or older at time of registration.
- Patient will provide written informed consent and authorization to release personal health information.
Exclusion Criteria
- No known history of anticipatory nausea or vomiting.
- No use of another antiemetic agent within 72 hours prior to beginning chemotherapy.
- No known central nervous system (CNS) metastasis.
- No known hypersensitivity to any component of study regimen.
- No concurrent participation in a clinical trial which involves another investigational agent.
- No use of warfarin while on study.
- No use of agents expected to induce the metabolism of aprepitant which include: Rifampin, Rifabutin, Phenytoin, Carbamazepine, and barbiturates.
- No use of agents which may impair metabolism of aprepitant which include: Cisapride, macrolide antibiotics (Erythromycin, Clarithromycin, Azithromycin), azole antifungal agents (Ketoconazole, Itraconazole, Voriconazole, Fluconazole), Amifostine, Nelfinavir and Ritonavir.
Data sourced from ClinicalTrials.gov (NCT00572572). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.