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

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ClinicalTrials.gov Identifier: NCT00553059

Recruitment Status : Completed

First Posted : November 4, 2007

Results First Posted : October 9, 2020

Last Update Posted : October 9, 2020

Sponsor:

Collaborators:

National Cancer Institute (NCI)

Solvay Pharmaceuticals

Information provided by (Responsible Party):

M.D. Anderson Cancer Center

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Chemotherapy-induced Nausea and Vomiting Unspecified Adult Solid Tumor, Protocol Specific	Drug: dexamethasone Drug: dronabinol Drug: palonosetron hydrochloride Other: placebo	Phase 3

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Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	62 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Supportive Care
Official Title:	Randomized, Double-Blind, Placebo-Controlled Trial of Palonosetron/Dexamethasone With or Without Dronabinol for the Prevention of Chemotherapy-Induced Nausea and Vomiting After Moderately Emetogenic Chemotherapy
Study Start Date :	May 2008
Actual Primary Completion Date :	August 2014
Actual Study Completion Date :	August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Dexamethasone Dronabinol Dexamethasone sodium phosphate Dexamethasone acetate Palonosetron

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm I: Palonosetron, Dexamethasone + Dronabinol Palonosetron hydrochloride intravenous (IV) and dexamethasone IV 30 minutes before chemotherapy administration on day 1, and oral dronabinol 3 times a day for 5 days beginning 30 minutes before chemotherapy administration on day 1.	Drug: dexamethasone 10 mg IV 30 minutes prior to administration of chemotherapy Drug: dronabinol 5 mg tablet by mouth three times a day beginning 30 minutes before chemotherapy Drug: palonosetron hydrochloride 0.25 mg IV 30 minutes prior to administration of chemotherapy
Active Comparator: Arm II: Palonosetron + Dexamethasone Palonosetron hydrochloride and dexamethasone as in arm I, and oral placebo 3 times a day for 5 days beginning 30 minutes before chemotherapy on day 1.	Drug: dexamethasone 10 mg IV 30 minutes prior to administration of chemotherapy Drug: palonosetron hydrochloride 0.25 mg IV 30 minutes prior to administration of chemotherapy Other: placebo 1 tablet by mouth three times a day beginning 30 minutes before chemotherapy

Outcome Measures

Primary Outcome Measures :

Number of Participants With Total Protection in the Acute, Delayed and Overall Periods [ Time Frame: 5 Days (first 5 days of the first cycle of chemotherapy) ]
Total protection is defined as no vomiting, no rescue therapy, and no nausea as indicated by responses to the acute (0-24 hour), delayed (24-120 hour), and overall (0-120 hour) periods as indicated by responses to the Daily Assessment of Nausea and Vomiting questionnaire. Data to be recorded in the study diary during the 5-day study period. The assessment measures in detail the occurrence, duration, and severity of post-chemotherapy nausea and emesis using a 10-point Likert-type scale ranging from 0 (none) to 10 (as bad as it could be) if nausea or vomiting is present.

Secondary Outcome Measures :

Number of Participants With Complete Protection for the Acute, Delayed, and Overall Periods [ Time Frame: Up to 5 days (first 5 days following first cycle of chemotherapy) ]
Complete Protection is no vomiting, no rescue therapy, and no nausea evaluated for the acute (0-24 hour), delayed (24-120 hour), and overall (0-120 hour) periods as indicated by responses to the Daily Assessment of Nausea and Vomiting questionnaire. The assessment measures in detail the occurrence, duration, and severity of post-chemotherapy nausea and emesis using a 10-point Likert-type scale ranging from 0 (none) to 10 (as bad as it could be) if nausea or vomiting is present.
Number of Participants With Complete Response for the Acute, Delayed, and Overall Periods [ Time Frame: Up to 5 days (first 5 days following first cycle of chemotherapy) ]
Complete response is defined as vomiting episodes with rescue medication evaluated for the acute (0-24 hour), delayed (24-120 hour), and overall (0-120 hour) periods as indicated by responses to the Daily Assessment of Nausea and Vomiting questionnaire. The assessment measures in detail the occurrence, duration, and severity of post-chemotherapy nausea and emesis using a 10-point Likert-type scale ranging from 0 (none) to 10 (as bad as it could be) if nausea or vomiting is present.
Number of Participants With Vomiting for the Acute, Delayed and Overall Periods [ Time Frame: 5 Days (first 5 days of the first cycle of chemotherapy) ]
Number of Participants with Vomiting Acute, Delayed and Overall. Evaluated for the acute (0-24 hour), delayed (24-120 hour), and overall (0-120 hour) periods as indicated by responses to the Daily Assessment of Nausea and Vomiting questionnaire. The assessment measures in detail the occurrence, duration, and severity of post-chemotherapy nausea and emesis using a 10-point Likert-type scale ranging from 0 (none) to 10 (as bad as it could be) if nausea or vomiting is present.
Number of Participants With Nausea for the Acute, Delayed and Overall Periods [ Time Frame: 5 Days (first 5 days of the first cycle of chemotherapy) ]
Number of Participants with Nausea for the Acute, Delayed and Overall Periods. Evaluated for the acute (0-24 hour), delayed (24-120 hour), and overall (0-120 hour) periods as indicated by responses to the Daily Assessment of Nausea and Vomiting questionnaire. The assessment measures in detail the occurrence, duration, and severity of post-chemotherapy nausea and emesis using a 10-point Likert-type scale ranging from 0 (none) to 10 (as bad as it could be) if nausea or vomiting is present.
Number of Participants With Nausea and Vomiting for the Acute, Delayed and Overall Periods [ Time Frame: 5 Days (first 5 days of the first cycle of chemotherapy) ]
Number of Participants With Nausea and Vomiting for the Acute, Delayed and Overall Periods. Evaluated for the acute (0-24 hour), delayed (24-120 hour), and overall (0-120 hour) periods as indicated by responses to the Daily Assessment of Nausea and Vomiting questionnaire. The assessment measures in detail the occurrence, duration, and severity of post-chemotherapy nausea and emesis using a 10-point Likert-type scale ranging from 0 (none) to 10 (as bad as it could be) if nausea or vomiting is present.
Number of Participants Received Rescue Medication in the Acute, Delayed and Overall Periods [ Time Frame: 5 Days (first 5 days of the first cycle of chemotherapy) ]
The assessment measures in detail the occurrence, duration, and severity of post-chemotherapy nausea and emesis using a 10-point Likert-type scale ranging from 0 (none) to 10 (as bad as it could be) if nausea or vomiting is present. The first section asks the patient to record presence and severity of nausea during the last 24 hours. The second section asks the patient to record vomiting episodes during the last 24 hours. The third section asks if the patient took medication for nausea or vomiting during the last 24 hours and asks how useful the treatment for nausea or vomiting was. The fourth section screens for toxicity by asking about side effects and problems experienced during the last 24 hours. Use of rescue antiemetic medication and adverse events also assessed and documented.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.
Negative qualitative B-human chorionic gonadotropin (HCG) (pregnancy test)
Signed informed consent

Exclusion Criteria:

Scheduled to receive highly emetogenic chemotherapy (Hesketh Level 5 - such as cisplatin, 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 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
Uncontrolled primary or metastatic CNS tumor (including those with uncontrolled seizures)
Other physical causes for nausea or vomiting (such as bowel obstruction) not related to chemotherapy administration
Recent history of unexplained nausea or vomiting or history of frequent nausea or vomiting
Active bacterial or fungal infection for which administration of a corticosteroid would 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 the study period
Previous use of dronabinol or nabilone

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00553059

Locations

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United States, Missouri
Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
United States, Texas
University of Texas M.D. Anderson
Houston, Texas, United States, 77030-4009
United States, Vermont
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States, 05405

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Solvay Pharmaceuticals

Investigators

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Study Chair:	Steven M. Grunberg, MD	University of Vermont
Study Chair:	Amal I. Melhem-Bertrandt, MD	M.D. Anderson Cancer Center

More Information

Additional Information:

University of Texas MD Anderson Cancer Center Website This link exits the ClinicalTrials.gov site

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Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00553059
Other Study ID Numbers:	2006-0841 MDA-2006-0841 CDR0000573510 ( Other Identifier: NCI ) NCI-2009-00637 ( Registry Identifier: NCI CTRP )
First Posted:	November 4, 2007 Key Record Dates
Results First Posted:	October 9, 2020
Last Update Posted:	October 9, 2020
Last Verified:	October 2020

Keywords provided by M.D. Anderson Cancer Center:


nausea and vomiting unspecified adult solid tumor Palonosetron Dexamethasone

Additional relevant MeSH terms:

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Nausea Vomiting Signs and Symptoms, Digestive Dexamethasone Dronabinol Palonosetron Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists	Antineoplastic Agents, Hormonal Antineoplastic Agents Serotonin 5-HT3 Receptor Antagonists Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hallucinogens Psychotropic Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Cannabinoid Receptor Agonists Cannabinoid Receptor Modulators

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