Randomized, Double-Blind, Placebo-Controlled Trial of Palonosetron/Dexamethasone With or Without Dronabinol for the Prevention of Chemotherapy-Induced Nausea and Vomiting After Moderately Emetogenic Chemotherapy

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed solid tumors

- Receiving a moderately emetogenic chemotherapy regimen for the first time

- Patients may be chemotherapy naive or may have previously received a mildly
emetogenic agent, such as a taxane, if no nausea/vomiting was experienced with
that chemotherapy

- Scheduled to receive cyclophosphamide ≤ 1,500 mg/m^2 intravenous (IV) and/or
doxorubicin hydrochloride ≥ 40 mg/m^2 IV given as single doses on day 1 of
chemotherapy regimen

- Patients on combination regimens with these agents are eligible

- No concurrent moderately emetogenic chemotherapy (Hesketh Level 3-4) after day 1
of the study period

- Hesketh Level 1-2 chemotherapy on days 2-5 allowed

- No other physical causes for nausea or vomiting not related to chemotherapy
administration (i.e., bowel obstruction)

- No recent history of unexplained nausea or vomiting or history of frequent nausea or
vomiting

- No uncontrolled primary or metastatic central nervous system (CNS) tumor (including
those with uncontrolled seizures)

PATIENT CHARACTERISTICS:

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- White Blood Count (WBC) ≥ 3,000/mm^3

- Absolute granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Creatinine ≤ 1.5 * upper limit of normal (ULN)

- Bilirubin ≤ 2.5 * ULN

- Transaminases ≤ 2.5 * ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active bacterial or fungal infection for which administration of a corticosteroid
would be contraindicated

- No hypersensitivity to any of the study agents

- No sensitivity to sesame oil

- No previous poor tolerance of cannabinoids

- No habitual cannabinoid use or unwillingness to avoid the use of marijuana during the
study period

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- At least 30 days since prior treatment with any investigational agent

- No prior chemotherapy

- No prior dronabinol or nabilone

- No concurrent highly emetogenic chemotherapy (i.e.,cisplatin, streptozotocin,
dacarbazine, carmustine, hexamethylmelamine, mechlorethamine, procarbazine) [Hesketh
Level 5])

- No concurrent cranial, abdominal, or pelvic radiotherapy

- No concurrent corticosteroid treatment other than the study drug dose

- No other concurrent potential or known prophylactic antiemetic agents

- Chronically used benzodiazepines may be continued as a single nightly dose for
sleep

- No other concurrent investigational agents