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

Purpose

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	Intervention	Phase
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
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting

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

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Number of Participants with Total protection [ 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 Daily Assessment of Nausea and Vomiting questionnaire during the overall [0-120 hour] period.

Secondary Outcome Measures:

Acute, Delayed and Overall Total Protection [ Time Frame: Up to 5 days (first 5 days of the first cycle of chemotherapy) ]
Total protection is defined as 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.
Complete response and Complete Protection 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, and 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.


Enrollment:	62
Study Start Date:	May 2008
Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553059

Locations


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 CCOP Research Base
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


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


Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00553059 History of Changes
Other Study ID Numbers:	2006-0841 MDA-2006-0841 CDR0000573510 ( Other Identifier: NCI ) NCI-2009-00637 ( Registry Identifier: NCI CTRP )
Study First Received:	November 2, 2007
Last Updated:	September 4, 2014

Keywords provided by M.D. Anderson Cancer Center:


nausea and vomiting unspecified adult solid tumor Palonosetron Dexamethasone

Additional relevant MeSH terms:


Nausea Vomiting Signs and Symptoms, Digestive Signs and Symptoms Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate Dronabinol BB 1101 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 Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Hallucinogens Psychotropic Drugs Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on July 17, 2017