Palonosetron and Dexamethasone With or Without Dronabinol in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy For Cancer
Condition: Chemotherapy-induced Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Nausea; Vomiting
Intervention: dexamethasone; dronabinol; palonosetron hydrochloride; placebo
Intervention description: 10 mg IV 30 minutes prior to administration of chemotherapy; 5 mg tablet by mouth three times a day beginning 30 minutes before chemotherapy; 0.25 mg IV 30 minutes prior to administration of chemotherapy; 1 tablet by mouth three times a day beginning 30 minutes before chemotherapy
Intervention MeSH terms: Dexamethasone; Dronabinol; Palonosetron
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: nausea and vomiting; unspecified adult solid tumor; Palonosetron; Dexamethasone

Summary:

      The goal of this clinical research study is to learn if adding dronabinol in combination with
      the standard of care (dexamethasone and palonosetron) can better help to control nausea and
      vomiting in patients receiving chemotherapy. The safety of the drug combinations will also be
      studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically or cytologically documented solid tumor

          2. Receiving moderately emetogenic chemotherapy for the first time: Patients may be
             chemotherapy naive, or patients may have previously received a mildly emetogenic agent
             (such as a taxane) if no nausea/vomiting was experienced with that chemotherapy

          3. Scheduled to receive cyclophosphamide </= 1500 mg/m^2 IV and/or doxorubicin >/= 40
             mg/m^2 IV given as single doses on Day 1. Patients on combination regimens with these
             agents are eligible

          4. Age >/= 18 years

          5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

          6. Adequate organ reserve as follows: 1) Hematologic - white blood cell count (WBC) >/=
             3000/microL, AGC >/= 1500/microL, platelet >/= 100,000/microL; 2) Renal - Creatinine
             </= 1.5 times upper limit of normal; 3) Hepatic - Bilirubin and transaminases </= 2.5
             times upper limit of normal

          7. The effects of the three-drug regimen on the developing human fetus are unknown. For
             this reason, women of childbearing potential and men must agree to use adequate
             contraception (hormonal or barrier method of birth control; or abstinence) for the
             duration of study participation. Should a woman become pregnant or suspect she is
             pregnant while participating in this study, she should inform her treating physician
             immediately.

          8. Negative qualitative B-human chorionic gonadotropin (HCG) (pregnancy test)

          9. Signed informed consent

        Exclusion Criteria:

          1. Scheduled to receive highly emetogenic chemotherapy (Hesketh Level 5 - such as
             cisplatin, streptozotocin, dacarbazine, carmustine, hexamethylmelamine,
             mechlorethamine, procarbazine) during the study period

          2. Scheduled to receive moderately emetogenic chemotherapy (Hesketh Level 3-4) after Day
             1 of the study period

          3. Experienced nausea and/or vomiting with prior administration of chemotherapy

          4. Prior moderately or highly emetogenic chemotherapy: Patients may have previously
             received a mildly emetogenic agent (such as a taxane) if no nausea/vomiting was
             experienced with that chemotherapy

          5. Scheduled to receive cranial, abdominal, or pelvic radiation therapy during the study
             period

          6. Treatment with any investigational agent within 30 days of randomization

          7. Scheduled to receive treatment during the study period with other potential or known
             antiemetic agents. Chronically used benzodiazepines may be continued as a single
             nightly dose for sleep.

          8. Scheduled to receive corticosteroid treatment other than the study drug dose during
             the study period

          9. Uncontrolled primary or metastatic CNS tumor (including those with uncontrolled
             seizures)

         10. Other physical causes for nausea or vomiting (such as bowel obstruction) not related
             to chemotherapy administration

         11. Recent history of unexplained nausea or vomiting or history of frequent nausea or
             vomiting

         12. Active bacterial or fungal infection for which administration of a corticosteroid
             would be contraindicated

         13. Hypersensitivity to any of the study agents

         14. Sensitivity to sesame oil

         15. Planned simultaneous administration of any other investigational agents

         16. Pregnant or nursing women

         17. Previous poor tolerance of cannabinoids

         18. Habitual cannabinoid use or unwillingness to avoid the use of marijuana during the
             study period

         19. Previous use of dronabinol or nabilone