Clinical trial NCT03960151: Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy
Official title: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Germ Cell Tumor
Lead sponsor: Hoosier Cancer Research Network
Sponsor class: OTHER
Collaborators: name: Tesaro, Inc.
First posted: 2019-05-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Complete Response Rate
timeFrame: 8 Days
Secondary outcomes:
measure: Complete Response Rate: Acute Phase
timeFrame: 5 Days
measure: Complete Response Rate: Delayed Phase
timeFrame: 2 Days
measure: Frequency, intensity, and duration of nausea
timeFrame: 8 Days
measure: Frequency of vomiting or retching.
timeFrame: 8 Days
measure: Intensity of Vomiting or retching.
timeFrame: 8 Days
measure: Duration of Vomiting or retching
timeFrame: 8 Days
measure: Rate of no nausea
timeFrame: 8 Days
measure: Use of rescue medications
timeFrame: 8 Days
measure: Assess adverse events of regimen using CTCAE v4.
timeFrame: 8 Days
Other outcomes:
Locations:
Study officials:
affiliation: Indiana University Melvin and Bren Simon Cancer Center
name: Costantine Albany, MD
role: PRINCIPAL_INVESTIGATOR
References: