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

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 |

Arm | Intervention/treatment |
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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.
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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.
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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 |
- 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.
- 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.

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

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
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 |
Study Chair: | Steven M. Grunberg, MD | University of Vermont | |
Study Chair: | Amal I. Melhem-Bertrandt, MD | M.D. Anderson Cancer Center |
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 |
nausea and vomiting unspecified adult solid tumor Palonosetron Dexamethasone |
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 |