Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care, Treatment	Active	18 and over	NCI	MDA-2006-0841 2006-0841, NCT00553059

Objectives

1. 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.
2. 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.
3. To determine tolerability, in terms of treatment-limiting toxicities, observed with the three-drug combination.

Entry 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/m² IV and/or doxorubicin hydrochloride ≥ 40 mg/m² 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)

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

Patient Characteristics:

• ECOG performance status 0-2
• WBC ≥ 3,000/mm³
• Absolute granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• 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

Expected Enrollment

Outcomes

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)

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
Complete protection and complete response for the acute, delayed, and overall periods

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).

Trial Contact Information

Trial Lead Organizations

University of Texas M.D. Anderson CCOP Research Base

Steven Grunberg, MD, Protocol chair		Ph: 802-656-5457 Email: steven.grunberg@uvm.edu
Michael Fisch, MD, MPH, FACP, Protocol co-chair		Ph: 713-563-9905

U.S.A.
Missouri
	Springfield
	Cancer Research for the Ozarks
		Clinical Trial Office - Cancer Research for the Ozarks	Ph:  417-269-4520
South Carolina
	Greenville
	CCOP - Greenville
		Jeffrey Giguere, MD, FACP	Ph:  864-241-6251
Texas
	Houston
	University of Texas M.D. Anderson CCOP Research Base
		Michael Fisch, MD, MPH, FACP	Ph:  713-563-9905
Vermont
	Burlington
	Vermont Cancer Center at University of Vermont
		Steven Grunberg, MD	Ph:  802-656-5457
			Email: steven.grunberg@uvm.edu

Registry Information
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
Trial Start Date		2007-10-11
Trial Completion Date		2010-03-01 (estimated)
Registered in ClinicalTrials.gov		NCT00553059
Date Submitted to PDQ		2007-10-11
Information Last Verified		2009-06-07
NCI Grant/Contract Number		CA45809

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