APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer
Condition: Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Nausea; Vomiting
Intervention: APF530; dexamethasone; Palonosetron Hydrochloride; placebo
Intervention description: Given subcutanously; Given IV and orally; Given IV; Given subcutanously or IV
Intervention MeSH terms: Dexamethasone; Palonosetron
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1428.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: nausea and vomiting; unspecified adult solid tumor, protocol specific

Summary:

      This randomized phase III trial is studying APF530 and dexamethasone to see how well they
      work compared with palonosetron and dexamethasone in preventing nausea and vomiting in
      patients receiving chemotherapy for cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed malignant disease

               -  No head and neck cancer or upper gastrointestinal cancer

          -  Scheduled to receive a single day of moderately or highly emetogenic chemotherapy
             regimen (for ≤ 4 courses)

               -  Chemotherapy administration ≤ 4 hours

               -  Duration of each course ≤ 28 days

               -  Causing nausea and vomiting in 30-100% of patients if untreated according to
                  Hesketh algorithm

          -  Must be able to receive standardized doses of dexamethasone for the prevention of
             emesis during study treatment

          -  No greater than mild nausea or any vomiting within 24 hours before beginning study
             treatment

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No known allergy or hypersensitivity to other selective 5-HT3 receptor antagonists or
             local anesthetics

          -  QTc interval ≤ 500 ms

          -  No cardiac abnormality predisposing the patient to arrhythmia

          -  No psychological problem that, in the opinion of the investigator, is severe enough to
             preclude study participation

          -  No recent history (i.e., ≤ 1 year) of alcohol or drug abuse

          -  No concurrent condition that, in the opinion of the investigator, could affect
             assessment of study medication or interfere with the nausea/vomiting response (e.g.,
             severe renal or hepatic impairment)

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No radiotherapy 7 days prior to, during, and 5 days after completion of study
             treatment

          -  More than 7 days since prior chemotherapy

          -  More than 7 days since prior and no concurrent prohibited medications (e.g., CYP3A4
             inhibitors or other antiemetic medications)

          -  More than 7 days since prior antinausea medications

          -  More than 30 days since prior treatment on an investigational trial

          -  No other concurrent corticosteroids or dexamethasone at a different dose than study
             treatment

          -  No concurrent use of APF530, palonosetron hydrochloride, or aprepitant as rescue
             medications