Phase
Condition
Vomiting
Colic
Lactose Intolerance
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically or cytologically documented solid tumor
Receiving moderately emetogenic chemotherapy for the first time: Patients may bechemotherapy 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 >/= 40mg/m^2 IV given as single doses on Day 1. Patients on combination regimens with theseagents 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 </= 2.5times upper limit of normal
The effects of the three-drug regimen on the developing human fetus are unknown. Forthis reason, women of childbearing potential and men must agree to use adequatecontraception (hormonal or barrier method of birth control; or abstinence) for theduration of study participation. Should a woman become pregnant or suspect she ispregnant while participating in this study, she should inform her treating physicianimmediately.
Negative qualitative B-human chorionic gonadotropin (HCG) (pregnancy test)
Signed informed consent
Exclusion
Exclusion Criteria:
Scheduled to receive highly emetogenic chemotherapy (Hesketh Level 5 - such ascisplatin, streptozotocin, dacarbazine, carmustine, hexamethylmelamine,mechlorethamine, procarbazine) during the study period
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 previouslyreceived a mildly emetogenic agent (such as a taxane) if no nausea/vomiting wasexperienced with that chemotherapy
Scheduled to receive cranial, abdominal, or pelvic radiation therapy during the studyperiod
Treatment with any investigational agent within 30 days of randomization
Scheduled to receive treatment during the study period with other potential or knownantiemetic agents. Chronically used benzodiazepines may be continued as a singlenightly dose for sleep.
Scheduled to receive corticosteroid treatment other than the study drug dose duringthe study period
Uncontrolled primary or metastatic CNS tumor (including those with uncontrolledseizures)
Other physical causes for nausea or vomiting (such as bowel obstruction) not relatedto chemotherapy administration
Recent history of unexplained nausea or vomiting or history of frequent nausea orvomiting
Active bacterial or fungal infection for which administration of a corticosteroidwould be contraindicated
Hypersensitivity to any of the study agents
Sensitivity to sesame oil
Planned simultaneous administration of any other investigational agents
Pregnant or nursing women
Previous poor tolerance of cannabinoids
Habitual cannabinoid use or unwillingness to avoid the use of marijuana during thestudy period
Previous use of dronabinol or nabilone
Study Design
Study Description
Connect with a study center
Cancer Research for the Ozarks
Springfield, Missouri 65807
United StatesSite Not Available
CCOP - Greenville
Greenville, South Carolina 29615
United StatesSite Not Available
University of Texas M.D. Anderson
Houston, Texas 77030-4009
United StatesSite Not Available
Vermont Cancer Center at University of Vermont
Burlington, Vermont 05405
United StatesSite Not Available
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