Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2025-12-24 @ 2:51 PM
NCT ID:
NCT00553059
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00553059
Study Brief:
Protocol Section:
NCT00553059