Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy

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Brief Title

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.

Brief Summary

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


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Complete Response Rate

Secondary Outcome

 Complete Response Rate: Acute Phase

Condition

Germ Cell Tumor

Intervention

Rolapitant

Study Arms / Comparison Groups

 Rolapitant
Description:  Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

0

Start Date

May 2018

Completion Date

March 2022

Primary Completion Date

May 2021

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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Costantine Albany, MD, , 



Administrative Informations


NCT ID

NCT03960151

Organization ID

HCRN GU16-254


Responsible Party

Sponsor-Investigator

Study Sponsor

Costantine Albany

Collaborators

 Tesaro, Inc.

Study Sponsor

Costantine Albany, MD, Principal Investigator, Indiana University Melvin and Bren Simon Cancer Center


Verification Date

May 2019