Palonosetron and Dexamethasone With or Without Dronabinol in Preventing Nausea and Vomiting in Pa… (NCT00553059) | Clinical Trial Compass
CompletedPhase 3
Palonosetron and Dexamethasone With or Without Dronabinol in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy For Cancer
United States62 participantsStarted 2008-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Histologically or cytologically documented solid tumor
✓. 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
✓. 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
✓. Age \>/= 18 years
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
✓. 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
✓. 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.
✕. Scheduled to receive highly emetogenic chemotherapy (Hesketh Level 5 - such as cisplatin, streptozotocin, dacarbazine, carmustine, hexamethylmelamine, mechlorethamine, procarbazine) during the study period
What they're measuring
1
Number of Participants With Total Protection in the Acute, Delayed and Overall Periods
Timeframe: 5 Days (first 5 days of the first cycle of chemotherapy)
✕. Scheduled to receive moderately emetogenic chemotherapy (Hesketh Level 3-4) after Day 1 of the study period
✕. Experienced nausea and/or vomiting with prior administration of chemotherapy
✕. 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
✕. Scheduled to receive cranial, abdominal, or pelvic radiation therapy during the study period
✕. Treatment with any investigational agent within 30 days of randomization
✕. 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.
✕. Scheduled to receive corticosteroid treatment other than the study drug dose during the study period