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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00553059 |
Purpose
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 |
|---|---|---|
|
Nausea and Vomiting Unspecified Adult Solid Tumor, Protocol Specific |
Drug: dexamethasone Drug: dronabinol Drug: palonosetron hydrochloride Other: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind 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 |
| Estimated Enrollment: | 200 |
| Study Start Date: | October 2007 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
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.
|
Drug: dexamethasone
Given IV
Drug: dronabinol
Given orally
Drug: palonosetron hydrochloride
Given IV
|
|
Active Comparator: Arm II
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.
|
Drug: dexamethasone
Given IV
Drug: palonosetron hydrochloride
Given IV
Other: placebo
Given orally
|
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).
Eligibility| 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
Contacts and Locations| 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: Phoung K. Morrow, MD 713-792-2817 | |
| 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: | Phoung K. Morrow, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | Phoung Khanh Morrow, M. D. Anderson Cancer Center at University of Texas |
| ClinicalTrials.gov Identifier: | NCT00553059 History of Changes |
| Other Study ID Numbers: | CDR0000573510, MDA-2006-0841 |
| Study First Received: | November 2, 2007 |
| Last Updated: | March 26, 2011 |
| Health Authority: | Unspecified |
|
nausea and vomiting unspecified adult solid tumor, protocol specific |
|
Nausea Vomiting Signs and Symptoms, Digestive Signs and Symptoms Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate Tetrahydrocannabinol BB 1101 Palonosetron Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Hallucinogens Psychotropic Drugs Analgesics, Non-Narcotic |