Palonosetron and Dexamethasone With or Without Dronabinol in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy For Cancer

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI); Solvay Pharmaceuticals
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Dronabinol; Palonosetron

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/= 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 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