Rolapitant Hydrochloride in Preventing Nausea/Vomiting in Patients With Sarcoma Receiving Chemotherapy
Condition: Locally Advanced Sarcoma
MeSH terms: Sarcoma; Vomiting
Intervention: Dexamethasone; Doxorubicin; Fosaprepitant Dimeglumine; Ifosfamide; Laboratory Biomarker Analysis; Mesna; Ondansetron; Questionnaire Administration; Rolapitant Hydrochloride; Vincristine Sulfate
Intervention description: Given IV; Given IV; Given IV; Given IV; Correlative studies; Given IV; Given IV; Ancillary studies; Given PO; Given IV
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Doxorubicin; Liposomal doxorubicin; Vincristine; Daunorubicin; Ifosfamide; Isophosphamide mustard; Ondansetron; Fosaprepitant; Aprepitant; BB 1101; Rolapitant; Mesna
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies how well rolapitant hydrochloride works in preventing
      nausea/vomiting in patients with sarcoma receiving chemotherapy. Antiemetic drugs, such as
      rolapitant hydrochloride, may help control or prevent nausea and vomiting in patients treated
      with chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with sarcoma which is locally advanced, at high risk for relapse or
             metastatic for whom treatment with doxorubicin plus ifosfamide (AI) or AI and
             vincristine (VAI) is indicated

          -  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:

          -  Any current treatment, medical history, or uncontrolled condition, other than
             malignancy, (e.g., alcoholism or signs of alcohol abuse, seizure disorder, medical or
             psychiatric condition) that, in the opinion of the investigator, would confound the
             results of the study or pose any unwarranted risk in administering study drug to the
             subject

          -  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