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

Last updated: October 6, 2020
Sponsor: M.D. Anderson Cancer Center
Overall Status: Completed

Phase

3

Condition

Vomiting

Colic

Lactose Intolerance

Treatment

N/A

Clinical Study ID

NCT00553059
2006-0841
CDR0000573510
NCI-2009-00637
MDA-2006-0841
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologically or cytologically documented solid tumor

  2. 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

  3. 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

  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 </= 2.5times upper limit of normal

  7. 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.

  8. Negative qualitative B-human chorionic gonadotropin (HCG) (pregnancy test)

  9. Signed informed consent

Exclusion

Exclusion Criteria:

  1. Scheduled to receive highly emetogenic chemotherapy (Hesketh Level 5 - such ascisplatin, 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 previouslyreceived a mildly emetogenic agent (such as a taxane) if no nausea/vomiting wasexperienced with that chemotherapy

  5. Scheduled to receive cranial, abdominal, or pelvic radiation therapy during the studyperiod

  6. Treatment with any investigational agent within 30 days of randomization

  7. 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.

  8. Scheduled to receive corticosteroid treatment other than the study drug dose duringthe study period

  9. Uncontrolled primary or metastatic CNS tumor (including those with uncontrolledseizures)

  10. Other physical causes for nausea or vomiting (such as bowel obstruction) not relatedto chemotherapy administration

  11. Recent history of unexplained nausea or vomiting or history of frequent nausea orvomiting

  12. Active bacterial or fungal infection for which administration of a corticosteroidwould 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 thestudy period

  19. Previous use of dronabinol or nabilone

Study Design

Total Participants: 62
Study Start date:
May 01, 2008
Estimated Completion Date:
August 31, 2014

Study Description

The Study Drugs:

Dronabinol and palonosetron are both designed to help prevent nausea and vomiting in patients who are receiving chemotherapy.

Dexamethasone is a corticosteroid that is similar to a natural hormone made by your body. Dexamethasone is often given to MM patients in combination with other chemotherapy to treat cancer.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups.

  • If you are in Group 1, you will take dronabinol, dexamethasone, and palonosetron.

  • If you are in Group 2, you will take a placebo, dexamethasone, and palonosetron. A placebo is a substance that looks like the study drug but has no active ingredients.

You will have an equal chance of being assigned to either group. Neither you nor your doctor can choose the group you will be in. During the study, you and the study staff will not know which group you are in. However, if needed for your safety, the study staff will be able to find out which group you are in.

After the last study participant completes their study therapy, you and the study staff will find out which group you were in.

Study Drug Administration:

On Day 1 (the day that you receive chemotherapy), you will take a dronabinol/placebo pill by mouth every 8 hours (if possible). If you cannot take the pill every 8 hours, you should try to space out the doses evenly. Your first dronabinol/placebo pill on Day 1 will be 30 minutes before chemotherapy.

You will also receive dexamethasone and palonosetron by vein 30 minutes before you receive chemotherapy.

On Days 2-6, you will take dronabinol/placebo 3 times a day. You should take each pill every 8 hours (if possible). If you cannot take them every 8 hours, you should try to space out the doses evenly.

Study Diary:

You will complete a study diary on Days 1-6. In this diary you will answer questions about nausea and vomiting.

Study Visits:

You will have a study visit on Day 8 and again sometime during Days 14-28. At both visits, you will be asked if you have experienced any side effects. You should return your study diary to the clinic at both visits. At the visit during Days 14-28, you will also have a physical exam.

Length of Study:

You will be on study for 30 days. You will be taken off study early if the nausea and vomiting do not improve or intolerable side effects occur.

This is an investigational study. Dronabinol and palonosetron are both FDA approved and commercially available to prevent nausea and vomiting that may occur from chemotherapy. Dexamethasone is FDA approved and commercially available for the prevention of side effects related to chemotherapy. The combination of these drugs to prevent nausea and vomiting is investigational.

Up to 200 patients will take part in this multicenter study. Up to 200 will be enrolled at M. D. Anderson.

Connect with a study center

  • Cancer Research for the Ozarks

    Springfield, Missouri 65807
    United States

    Site Not Available

  • CCOP - Greenville

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • University of Texas M.D. Anderson

    Houston, Texas 77030-4009
    United States

    Site Not Available

  • Vermont Cancer Center at University of Vermont

    Burlington, Vermont 05405
    United States

    Site Not Available

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