None listed
Conditions
Brief summary
This is a trial of the drug Aprepitant for the prevention of chemotherapy-induced nausea and vomiting in people being treated for germ cell tumours with cisplatin-based chemotherapy. Who is it for? You can join this study if you: - have germ cell cancer that is at early or local, locally advanced or locally recurrent stage - are being treated with cisplatin-based chemotherapy. Trial details All participants receive anti-emetic (anti-vomiting or dry retching) treatment with Aprepitant for seven days while they are receiving their first cycle of Cisplatin-based chemotherapy. The study will measure the number of participants with no emesis during day 1 to 8 of chemotherapy. Chemotherapy-induced nausea and vomiting is an unpleasant side effect of chemotherapy for germ cell tumours, and this study hopes to minimise this.
Interventions
Anti-emetic regimen during five day Cisplatin-based chemotherapy Aprepitant 125mg Per Oral (PO) day 1 and 80mg Per Oral (PO) days 2 to 7. 5HT3 Antagonist days 1 to 5 Dexamethasone days 1 to 8.
Sponsors
The University of Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is 18 years or older. 2. Patient has a histologically or cytologically confirmed germ cell tumour. 3. Patient is scheduled to recieve a 5 day Cisplatin (20mg per metre square) based chemotherapy. Ie: Any of: BEP (Cisplatin, Etoposide, Bleomycin: Indiana Regimen); Accelerated BEP (ANZGCTG Regimen); VIP (Cisplatin, Ifosfamide, Etoposide); VeIP (Cisplatin, Ifosamide, Vinblastine); or TIP (Paclitaxel, Ifosfamide, Cisplatin). 4. Patient has a predicted life expectancy of 4 months or more. 5. Patient has an ECOG performance score of 3 or less. 6. Patient is able to read, understand and complete patient diary. 7. Patient is able to understand study procedures and agrees to participate in the study by giving written informed consent.
Exclusion criteria
1. Patient has vomited in the 24 hours prior to Treatment Day 1. 2. Previous chemotherapy. 3. Patient has a symptomatic metastatic CNS malignancy. 4. Patient has recieved radiation therapy to the abdomen or pelvis in the week prior to treatment, or will recieve radiation therapy to the abdomen or pelvis during days one to eight of treatment. 5. Patient has an active infection (e.g. pneumonia) or any uncontrolled disease except for malignancy (e.g diabetic ketoacidosis, gastrointestinal obstruction) which, in the opinion of the investigator, might confound the results of the study or pose unwarranted risk. 6. Patient has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose unwarranted risk. 7. Patient has current evidence of alcohol abuse as determined by the investigator. 8. Patient is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry. 9. Patient has a history of hypersensitivity to Aprepitant, Ondansetron, or Dexamethasone. 10. Patient has previously participated in a study with Aprepitant. 11. Patient has taken any of the following CYP3A4 substrates during the 7 days of treatment day 1: Terfenadine, Cisapride, Astemizole, or Pimozide.
Outcome results
None listed