Phase II study of Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone in patients with germ cell tumors undergoing 5-day Cisplatin-based chemotherapy
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Rolapitant 180mg PO, Days 1 and 5
Palonosetron 0.25 mg IV, Days 1,3, and 5.
Olanzapine 10 mg PO PM, Days 2,3,4,5,6-8
Complete Response Rate
Determine the complete response (CR) rate defined as no emesis and no use of rescue medications in germ cell tumor patients treated with rolapitant plus Olanzapine in combination with palonosetron a 5HT3RA and dexamethasone on Cycle 1 Day 1 through Day 8
Time frame: 8 Days
Complete Response Rate: Acute Phase
Determine the CR rate in the acute phase (Days 1-5) defined as no emesis and no use of rescue medications in germ cell tumor patients treated with rolapitant plus Olanzapine in combination with palonosetron a 5HT3RA and dexamethasone on Cycle 1 Day 1 through Day 5
Time frame: 5 Days
Complete Response Rate: Delayed Phase
Determine the CR rate in the delayed phase (Days 6-8) defined as no emesis and no use of rescue medications in germ cell tumor patients treated with rolapitant plus Olanzapine in combination with palonosetron a 5HT3RA and dexamethasone on Cycle 1 Day 6 through Day 8
Time frame: 2 Days
Frequency, intensity, and duration of nausea
Determine the frequency, intensity and duration of nausea on Days 1-8 in Cycle 1. The frequency, intensity and duration of nausea will be captured via daily self-assessment patient logs.
Time frame: 8 Days
Frequency of vomiting or retching.
Determine the frequency, intensity and duration of vomiting or retching on Days 1-8 in Cycle 1. The frequency of vomiting and retching will be captured via daily self-assessment patient logs.
Time frame: 8 Days
Intensity of Vomiting or retching.
Determine the intensity of vomiting or retching on Days 1-8 in Cycle 1. The intensity of vomiting and retching will be captured via daily self-assessment patient logs.
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Dexamethasone 20 mg AM, Days 1,2 and 3
Time frame: 8 Days
Duration of Vomiting or retching
Determine the duration of vomiting or retching on Days 1-8 in Cycle 1. The duration of vomiting and retching will be captured via daily self-assessment patient logs.
Time frame: 8 Days
Rate of no nausea
Determine the rate of no nausea defined as \< 5mm on a 0-100mm visual analog scale (VAS) on Days 1-5 and Days 6-8 on Cycle 1
Time frame: 8 Days
Use of rescue medications
Describe the use of rescue medications as defined in the protocol
Time frame: 8 Days
Assess adverse events of regimen using CTCAE v4.
Safety and toxicity will be assessed using CTCAE v4
Time frame: 8 Days