Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy

Germ Cell Tumor Clinical Trial

Official title:

Phase II Study of Rolapitant Plus Olanzapine, Palonosetron, and Dexamethasone in Patients With Germ Cell Tumors Undergoing 5-day Cisplatin-based Chemotherapy.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03960151
• Other study ID #: HCRN GU16-254
• Status: Withdrawn
• Phase: Phase 2
• Start date: May 2018
• Est. completion date: March 2022

Study information

• Verified date: May 2019
• Source: Hoosier Cancer Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase II study of Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone in patients with germ cell tumors undergoing 5-day Cisplatin-based chemotherapy

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2022
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Germ Cell Tumor
• Neoplasms, Germ Cell and Embryonal

Intervention

Drug:
• Rolapitant
Rolapitant 180mg PO, Days 1 and 5
• Palonosetron
Palonosetron 0.25 mg IV, Days 1,3, and 5.
• Olanzapine
Olanzapine 10 mg PO PM, Days 2,3,4,5,6-8
• Dexamethasone
Dexamethasone 20 mg AM, Days 1,2 and 3

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Costantine Albany	Tesaro, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	8 Days
Secondary	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	5 Days
Secondary	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	2 Days
Secondary	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.	8 Days
Secondary	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.	8 Days
Secondary	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.	8 Days
Secondary	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.	8 Days
Secondary	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	8 Days
Secondary	Use of rescue medications	Describe the use of rescue medications as defined in the protocol	8 Days
Secondary	Assess adverse events of regimen using CTCAE v4.	Safety and toxicity will be assessed using CTCAE v4	8 Days