Rolapitant Hydrochloride in Preventing Nausea/Vomiting in Patients With Sarcoma Receiving Chemotherapy
NCT ID: NCT02732015
Last Updated: 2021-08-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
37 participants
INTERVENTIONAL
2016-10-12
2020-07-10
Brief Summary
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Detailed Description
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I. To evaluate the effect of rolapitant hydrochloride (rolapitant) on nausea/vomiting in patients with sarcoma receiving multi-day highly emetogenic chemotherapy (HEC) regimen of doxorubicin and ifosfamide (AI).
SECONDARY OBJECTIVES:
I. To evaluate the toxicity of rolapitant in patients receiving AI regimen. II. To evaluate the effects of rolapitant on patient reported outcomes.
OUTLINE:
PART I: Patients receive dexamethasone intravenously (IV) daily and ondansetron IV on days 1-5, and rolapitant hydrochloride orally (PO) on day 1.
PART II: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive treatment as in part I. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive dexamethasone IV and ondansetron IV on days 1-5, and fosaprepitant dimeglumine IV over 30 minutes on days 1 of cycle 2. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
CHEMOTHERAPY: All patients receive doxorubicin IV over 72 hours, mesna IV, and ifosfamide IV over 3 hours on days 1-4 or 1-5. Patients with sarcomas of small cell histology receive vincristine sulfate IV on day 1. Cycles repeat every 3 weeks following blood count and patient recovery from any acute toxicities.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (rolapitant hydrochloride)
Patients receive treatment as in part I. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
CHEMOTHERAPY: All patients receive doxorubicin IV over 72 hours, mesna IV, and ifosfamide IV over 3 hours on days 1-4 or 1-5. Patients with sarcomas of small cell histology receive vincristine sulfate IV on day 1. Cycles repeat every 3 weeks following blood count and patient recovery from any acute toxicities.
Dexamethasone
Given IV
Doxorubicin
Given IV
Ifosfamide
Given IV
Laboratory Biomarker Analysis
Correlative studies
Mesna
Given IV
Ondansetron
Given IV
Questionnaire Administration
Ancillary studies
Rolapitant Hydrochloride
Given PO
Vincristine Sulfate
Given IV
Arm II (fosaprepitant dimeglumine)
Patients receive dexamethasone IV and ondansetron IV on days 1-5, and fosaprepitant dimeglumine IV over 30 minutes on days 1 of cycle 2. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
CHEMOTHERAPY: All patients receive doxorubicin IV over 72 hours, mesna IV, and ifosfamide IV over 3 hours on days 1-4 or 1-5. Patients with sarcomas of small cell histology receive vincristine sulfate IV on day 1. Cycles repeat every 3 weeks following blood count and patient recovery from any acute toxicities.
Dexamethasone
Given IV
Doxorubicin
Given IV
Fosaprepitant Dimeglumine
Given IV
Ifosfamide
Given IV
Laboratory Biomarker Analysis
Correlative studies
Mesna
Given IV
Ondansetron
Given IV
Questionnaire Administration
Ancillary studies
Vincristine Sulfate
Given IV
Interventions
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Dexamethasone
Given IV
Doxorubicin
Given IV
Fosaprepitant Dimeglumine
Given IV
Ifosfamide
Given IV
Laboratory Biomarker Analysis
Correlative studies
Mesna
Given IV
Ondansetron
Given IV
Questionnaire Administration
Ancillary studies
Rolapitant Hydrochloride
Given PO
Vincristine Sulfate
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient must have an estimated life expectancy \>= 4 months in the opinion of the investigators
* Male and females of child bearing potential must use acceptable methods of birth control which include oral contraceptives, spermicide with either a condom, diaphragm or cervical cap, use of an intrauterine device (IUD) or abstinence
* Female patients must have a negative pregnancy test at screening
* Female patients of childbearing potential must agree to use an acceptable method of birth control (excluding hormonal birth control methods) for 72 hours prior to admission and to continue its use during the study and for at least 30 days after the final dose
* Male patients must agree to use an acceptable form of birth control from study day 1 through at least 30 days after the final dose
* Absolute neutrophil count (ANC) \> 1500/mm\^3
* Platelet count \> 100,000/mm\^3
* Serum creatinine \< 1.5 mg/dL
* Serum bilirubin count \< 1.5 x upper limit normal (ULN)
* Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) \< 2.5 x ULN; for subjects with known liver metastases \< 5 x ULN
* Karnofsky performance status \> 60%
* Signed informed consent form
* Patients are required to read and understand English to comply with protocol requirements
Exclusion Criteria
* Patient has a known hypersensitivity to the administration of any prescribed oral or intravenous study medication or metabolite, including but not limited to, a history of hypersensitivity to the drugs or their components, severe renal impairment, severe bone marrow suppression, or systemic infection
* Patient is a woman with a positive urine or serum pregnancy test within 3 days prior to study drug administration, is breast-feeding, or is planning to conceive children within the projected duration of the study treatment
* Patient has taken the anti-emetic agents within the last 48 hours prior to the start of treatment with study drug:
* 5-hydroxytryptamine (HT)3 antagonists (ondansetron, granisetron, dolasetron, tropisetron, etc.); palonosetron is not permitted within 7 days prior to administration of investigational product
* Phenothiazines (prochlorperazine, fluphenazine, perphenazine, thiethylperazine, chlorpromazine, etc.)
* Benzamides (metoclopramide, alizapride, etc.)
* Domperidone
* Cannabinoids
* Neurokinin (NK)1 antagonist (aprepitant)
* Benzodiazepines (lorazepam, alprazolam, etc)
* Herbal medications or preparations in doses designed to ameliorate nausea or emesis
* Patient has received systemic corticosteroids or sedative antihistamines (dimenhydrinate, diphenhydramine, etc.) within 72 hours of day 1 of the study except as premedication for chemotherapy (e.g., taxanes); subjects who are receiving inhaled steroids for respiratory conditions or topical steroids for skin disorders can be enrolled
* Patient has symptomatic primary or metastatic central nervous system (CNS) disease
* Patient has ongoing vomiting, retching, dry heaves, or clinically significant nausea caused by any etiology, or has had such symptoms within 24 hours prior to the start of day 1 of the study intervention, or has a history of anticipatory nausea and vomiting
* Patient must not have been dosed with test drug or blinded study drug in another investigational study within 30 days or 5 half-lives of the biologic activity of the test drug, whichever is longer, before the time of first study dose
* Patient who is participating in any investigational agent that is not Food and Drug Administration (FDA)-approved
* Patient has uncontrolled angina, congestive heart failure (New York Heart Association \> class II or known ejection fraction \< 40%), uncontrolled cardiac arrhythmia or hypertension, or acute myocardial infarction within 3 months
* Prior surgery or radiotherapy (RT) within 2 weeks of study entry
* Psychological, social, familial, or geographical reasons that would prevent scheduled visits and follow-up
18 Years
65 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Saroj Vadhan
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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NCI-2016-00801
Identifier Type: REGISTRY
Identifier Source: secondary_id
2015-0587
Identifier Type: OTHER
Identifier Source: secondary_id
2015-0587
Identifier Type: -
Identifier Source: org_study_id
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