Germ Cell Tumor
Conditions
Brief summary
Phase II study of Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone in patients with germ cell tumors undergoing 5-day Cisplatin-based chemotherapy
Interventions
DRUGRolapitant
Rolapitant 180mg PO, Days 1 and 5
DRUGPalonosetron
Palonosetron 0.25 mg IV, Days 1,3, and 5.
DRUGOlanzapine
Olanzapine 10 mg PO PM, Days 2,3,4,5,6-8
DRUGDexamethasone
Dexamethasone 20 mg AM, Days 1,2 and 3
Sponsors
Tesaro, Inc.
Costantine Albany
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. * Age ≥ 15 years at the time of consent. * Must be able to take oral medications (swallow pills) * ECOG Performance Status of 0-2 within 14 days prior to registration. * Histological or serological confirmation of germ cell tumor planning on receiving a standard 5 day cisplatin based chemotherapy regimen. * Patients must have had no nausea or vomiting for 24 hours and no antiemetic use for 72 hours prior to starting protocol therapy. * No active central nervous system (CNS) metastases. Patients with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis. A subject with prior brain metastasis may be considered if they have completed their treatment for brain metastasis at least 4 weeks prior to study registration, have been off of corticosteroids for ≥ 2 weeks, and are asymptomatic. * Prior cancer treatments are not allowed. Patients have to be chemotherapy naïve. * Absolute Neutrophil Count (ANC) ≥ 1 K/mm3 * Hemoglobin (Hgb) ≥ 10 g/dL * Platelets (Plt) ≥ 100 K/mm3 * Creatinine ≤ 2 mg/dL * Bilirubin ≤ 1.5 × upper limit of normal (ULN) * Aspartate aminotransferase (AST) ≤ 2.5 × ULN * Alanine aminotransferase (ALT) ≤ 2.5 × ULN * No concurrent use of thioridazine or pimozide. No use of agents expected to induce the metabolism of rolapitant which include: Rifampin, Rifabutin, Phenytoin, Carbamazepine, and Barbiturates. * As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study * Patients and their partners must agree to use a highly effective method of birth control from the signing of the informed consent form until 90 days following the last dose of rolapitant.
Exclusion criteria
* Any untreated central nervous system (CNS) metastases. * Treatment with any investigational drug within 30 days prior to registration. * Concurrent participation in a clinical trial which involves another investigational agent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response Rate | 8 Days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response Rate: Delayed Phase | 2 Days | 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 |
| Frequency, intensity, and duration of nausea | 8 Days | 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. |
| Frequency of vomiting or retching. | 8 Days | 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. |
| Intensity of Vomiting or retching. | 8 Days | 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. |
| Complete Response Rate: Acute Phase | 5 Days | 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 |
| Rate of no nausea | 8 Days | 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 |
| Use of rescue medications | 8 Days | Describe the use of rescue medications as defined in the protocol |
| Assess adverse events of regimen using CTCAE v4. | 8 Days | Safety and toxicity will be assessed using CTCAE v4 |
| Duration of Vomiting or retching | 8 Days | 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. |
Outcome results
None listed