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

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:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Nausea and Vomiting

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus RS 25233-197 Palonosetron Hydrochloride Dexamethasone Sodium Phosphate Tetrahydrocannabinol

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Total protection (i.e., 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) [ Designated as safety issue: No ]

Secondary Outcome Measures:

No vomiting, no significant nausea, and no nausea evaluated for the acute (0-24 hour), delayed (24-120 hour), and overall (0-120 hour) periods [ Designated as safety issue: No ]
Complete protection and complete response for the acute, delayed, and overall periods [ Designated as safety issue: No ]

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
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.	Drug: dexamethasone Given IV Drug: dronabinol Given orally Drug: palonosetron hydrochloride Given IV
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.	Drug: dexamethasone Given IV Drug: palonosetron hydrochloride Given IV Other: placebo Given orally

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 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
- 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
  - 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 CNS tumor (including those with uncontrolled seizures)

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
WBC ≥ 3,000/mm^3
Absolute granulocyte count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Creatinine ≤ 1.5 x upper limit of normal (ULN)
Bilirubin ≤ 2.5 x ULN
Transaminases ≤ 2.5 x 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, altretamine, mechlorethamine hydrochloride, or procarbazine hydrochloride [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	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

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:	Steven M. Grunberg, MD	University of Vermont
Investigator:	Michael J. Fisch, MD, MPH, FACP	M.D. Anderson Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Texas M.D. Anderson CCOP Research Base ( Michael J. Fisch )
Study ID Numbers:	CDR0000573510, MDA-2006-0841
Study First Received:	November 2, 2007
Last Updated:	June 9, 2009
ClinicalTrials.gov Identifier:	NCT00553059 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

nausea and vomiting
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Dexamethasone
Anti-Inflammatory Agents
Neurotransmitter Agents
Vomiting
Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Psychotropic Drugs
Antiemetics
Hallucinogens
Hormones
Signs and Symptoms
Serotonin Antagonists

Sensory System Agents
Therapeutic Uses
Nausea
Analgesics
Dexamethasone acetate
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Glucocorticoids
Pharmacologic Actions
Tetrahydrocannabinol
Palonosetron
Serotonin Agents
Autonomic Agents
Analgesics, Non-Narcotic
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009