Palonosetron and Dexamethasone With or Without Dronabinol in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy For Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific
Intervention: dexamethasone (Drug); dronabinol (Drug); palonosetron hydrochloride (Drug); placebo (Other)
Phase: Phase 3
Sponsored by: M.D. Anderson Cancer Center
Official(s) and/or principal investigator(s):
Steven M. Grunberg, MD, Study Chair, Affiliation: University of Vermont
Phoung K. Morrow, MD, Affiliation: M.D. Anderson Cancer Center
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
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
Study design: Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Primary outcome: 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
- 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
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
- 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).
Minimum age: 18 Years.
Maximum age: N/A.
- 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
- 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
- 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
- No uncontrolled primary or metastatic CNS tumor (including those with uncontrolled
- 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
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
- 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
- No other concurrent investigational agents
Locations and Contacts
Cancer Research for the Ozarks, Springfield, Missouri 65807, United States; Recruiting
Clinical Trial Office - Cancer Research for the Ozarks, Phone: 417-269-4520
CCOP - Greenville, Greenville, South Carolina 29615, United States; Recruiting
Jeffrey K. Giguere, MD, FACP, Phone: 864-241-6251
University of Texas M.D. Anderson CCOP Research Base, Houston, Texas 77030-4009, United States; Recruiting
Phoung K. Morrow, MD, Phone: 713-792-2817
Vermont Cancer Center at University of Vermont, Burlington, Vermont 05405, United States; Recruiting
Steven M. Grunberg, MD, Phone: 802-656-5457, Email: firstname.lastname@example.org
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: October 2007
Last updated: March 26, 2011