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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00553059 |
RATIONALE: Antiemetic drugs, such as dexamethasone, palonosetron, and dronabinol may help lessen or prevent nausea and vomiting caused by chemotherapy. It is not yet known whether giving dronabinol together with palonosetron and dexamethasone is more effective than giving palonosetron and dexamethasone in preventing nausea and vomiting caused by chemotherapy.
PURPOSE: This randomized phase III trial is studying giving dronabinol together with palonosetron and dexamethasone to see how well they work compared to giving palonosetron and dexamethasone alone in preventing nausea and vomiting in patients undergoing chemotherapy for cancer.
Condition | Intervention | Phase |
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Nausea and Vomiting Unspecified Adult Solid Tumor, Protocol Specific |
Drug: dexamethasone Drug: dronabinol Drug: palonosetron hydrochloride Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control |
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 |
Estimated Enrollment: | 200 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive palonosetron hydrochloride IV and dexamethasone IV 30 minutes before chemotherapy administration on day 1. Patients also receive oral dronabinol 3 times a day for 5 days beginning 30 minutes before chemotherapy administration on day 1.
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Drug: dexamethasone
Given IV
Drug: dronabinol
Given orally
Drug: palonosetron hydrochloride
Given IV
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Arm II: Active Comparator
Patients receive palonosetron hydrochloride and dexamethasone as in arm I. Patients also receive an oral placebo 3 times a day for 5 days beginning 30 minutes before chemotherapy on day 1.
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Drug: dexamethasone
Given IV
Drug: palonosetron hydrochloride
Given IV
Drug: placebo
Given orally
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OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to study center. Patients receive scheduled chemotherapy (cyclophosphamide and/or doxorubicin hydrochloride) beginning on day 1. Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment continues in the absence of nausea or vomiting within 24 hours after initiation of chemotherapy.
Patients complete a Daily Assessment of Nausea and Vomiting questionnaire after the administration of chemotherapy on days 1-5.
Patients are followed at the completion of course 1 of chemotherapy (days 14-28).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Receiving a moderately emetogenic chemotherapy regimen for the first time
Scheduled to receive cyclophosphamide ≤ 1,500 mg/m^2 IV and/or doxorubicin hydrochloride ≥ 40 mg/m^2 IV given as single doses on day 1 of chemotherapy regimen
No concurrent moderately emetogenic chemotherapy (Hesketh Level 3-4) after day 1 of the study period
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No other concurrent potential or known prophylactic antiemetic agents
United States, Missouri | |
Cancer Research for the Ozarks | Recruiting |
Springfield, Missouri, United States, 65807 | |
Contact: Clinical Trial Office - Cancer Research for the Ozarks 417-269-4520 | |
United States, South Carolina | |
CCOP - Greenville | Recruiting |
Greenville, South Carolina, United States, 29615 | |
Contact: Jeffrey K. Giguere, MD, FACP 864-241-6251 | |
United States, Texas | |
University of Texas M.D. Anderson CCOP Research Base | Recruiting |
Houston, Texas, United States, 77030-4009 | |
Contact: Michael J. Fisch, MD, MPH, FACP 713-563-9905 | |
United States, Vermont | |
Vermont Cancer Center at University of Vermont | Recruiting |
Burlington, Vermont, United States, 05405 | |
Contact: Steven M. Grunberg, MD 802-656-5457 steven.grunberg@uvm.edu |
Study Chair: | Steven M. Grunberg, MD | University of Vermont |
Investigator: | Michael J. Fisch, MD, MPH, FACP | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000573510, MDA-2006-0841 |
Study First Received: | November 2, 2007 |
Last Updated: | January 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00553059 |
Health Authority: | Unspecified |
nausea and vomiting unspecified adult solid tumor, protocol specific |
Tetrahydrocannabinol Dexamethasone Signs and Symptoms Palonosetron Vomiting |
Signs and Symptoms, Digestive Nausea Serotonin Dexamethasone acetate |
Anti-Inflammatory Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Psychotropic Drugs Gastrointestinal Agents Hormones, Hormone Substitutes, and Hormone Antagonists Hallucinogens Antiemetics Glucocorticoids |
Hormones Pharmacologic Actions Serotonin Antagonists Serotonin Agents Sensory System Agents Analgesics, Non-Narcotic Autonomic Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents |