Palonosetron and Dexamethasone With or Without Dronabinol in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy For Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00553059
First received: November 2, 2007
Last updated: November 9, 2012
Last verified: November 2012
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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 |
|---|---|---|
|
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 Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, 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:
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dronabinol
Dexamethasone sodium phosphate
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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 200 |
| Study Start Date: | October 2007 |
| Estimated Primary Completion Date: | March 2013 (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
|
Detailed Description:
OBJECTIVES:
- To determine whether dronabinol can add significantly to the antiemetic protection provided by a standard palonosetron hydrochloride and dexamethasone regimen for patients receiving moderately emetogenic chemotherapy.
- To determine the tolerability of dronabinol when added to a regimen of dexamethasone and palonosetron hydrochloride administered for the prevention of acute and delayed nausea and vomiting caused by moderately emetogenic chemotherapy.
- To determine tolerability, in terms of treatment-limiting toxicities, observed with the three-drug combination.
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.
- Arm I: Patients receive palonosetron hydrochloride intravenous (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.
- 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.
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 |
Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed solid tumors
Receiving a moderately emetogenic chemotherapy regimen for the first time
- Patients may be chemotherapy naive or 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 ≤ 1,500 mg/m^2 intravenous (IV) and/or doxorubicin hydrochloride ≥ 40 mg/m^2 IV given as single doses on day 1 of chemotherapy regimen
- Patients on combination regimens with these agents are eligible
No concurrent moderately emetogenic chemotherapy (Hesketh Level 3-4) after day 1 of the study period
- Hesketh Level 1-2 chemotherapy on days 2-5 allowed
- No other physical causes for nausea or vomiting not related to chemotherapy administration (i.e., bowel obstruction)
- No recent history of unexplained nausea or vomiting or history of frequent nausea or vomiting
- No uncontrolled primary or metastatic central nervous system (CNS) tumor (including those with uncontrolled seizures)
PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- White Blood Count (WBC) ≥ 3,000/mm^3
- Absolute granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Creatinine ≤ 1.5 * upper limit of normal (ULN)
- Bilirubin ≤ 2.5 * ULN
- Transaminases ≤ 2.5 * ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active bacterial or fungal infection for which administration of a corticosteroid would be contraindicated
- No hypersensitivity to any of the study agents
- No sensitivity to sesame oil
- No previous poor tolerance of cannabinoids
- No habitual cannabinoid use or unwillingness to avoid the use of marijuana during the study period
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 30 days since prior treatment with any investigational agent
- No prior chemotherapy
- No prior dronabinol or nabilone
- No concurrent highly emetogenic chemotherapy (i.e.,cisplatin, streptozotocin, dacarbazine, carmustine, hexamethylmelamine, mechlorethamine, procarbazine) [Hesketh Level 5])
- No concurrent cranial, abdominal, or pelvic radiotherapy
- No concurrent corticosteroid treatment other than the study drug dose
No other concurrent potential or known prophylactic antiemetic agents
- Chronically used benzodiazepines may be continued as a single nightly dose for sleep
- No other concurrent investigational agents
Contacts and Locations
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
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:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00553059 History of Changes |
| Other Study ID Numbers: | 2006-0841, MDA-2006-0841, CDR0000573510 |
| Study First Received: | November 2, 2007 |
| Last Updated: | November 9, 2012 |
| Health Authority: | United States: Federal Government |
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 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 |
ClinicalTrials.gov processed this record on May 16, 2013