Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy
Study Details
Study Description
Brief Summary
Phase II study of Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone in patients with germ cell tumors undergoing 5-day Cisplatin-based chemotherapy
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Rolapitant Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone |
Drug: Rolapitant
Rolapitant 180mg PO, Days 1 and 5
Other Names:
Drug: Palonosetron
Palonosetron 0.25 mg IV, Days 1,3, and 5.
Other Names:
Drug: Olanzapine
Olanzapine 10 mg PO PM, Days 2,3,4,5,6-8
Other Names:
Drug: Dexamethasone
Dexamethasone 20 mg AM, Days 1,2 and 3
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- 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.
- 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.
- 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
Eligibility Criteria
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.
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Age ≥ 15 years at the time of consent.
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Must be able to take oral medications (swallow pills)
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ECOG Performance Status of 0-2 within 14 days prior to registration.
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Histological or serological confirmation of germ cell tumor planning on receiving a standard 5 day cisplatin based chemotherapy regimen.
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Patients must have had no nausea or vomiting for 24 hours and no antiemetic use for 72 hours prior to starting protocol therapy.
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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.
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Prior cancer treatments are not allowed. Patients have to be chemotherapy naïve.
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Absolute Neutrophil Count (ANC) ≥ 1 K/mm3
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Hemoglobin (Hgb) ≥ 10 g/dL
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Platelets (Plt) ≥ 100 K/mm3
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Creatinine ≤ 2 mg/dL
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Bilirubin ≤ 1.5 × upper limit of normal (ULN)
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Aspartate aminotransferase (AST) ≤ 2.5 × ULN
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Alanine aminotransferase (ALT) ≤ 2.5 × ULN
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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.
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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
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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:
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Any untreated central nervous system (CNS) metastases.
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Treatment with any investigational drug within 30 days prior to registration.
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Concurrent participation in a clinical trial which involves another investigational agent.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Costantine Albany
- Tesaro, Inc.
Investigators
- Principal Investigator: Costantine Albany, MD, Indiana University Melvin and Bren Simon Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HCRN GU16-254