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
| City: |
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Burlington |
| State: |
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Vermont |
| Zip Code: |
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05405 |
| Conditions: |
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Nausea and Vomiting - Unspecified Adult Solid Tumor, Protocol Specific |
| Purpose: |
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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.
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| Study Summary: |
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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).
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| Criteria: |
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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 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, 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
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| NCT ID: |
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NCT00553059 |
| Primary Contact: |
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Study Chair
Steven M. Grunberg, MD
University of Vermont
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| Backup Contact: |
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N/A |
| Location Contact: |
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Burlington, Vermont 05405
United States
Steven M. Grunberg, MD
Phone: 802-656-5457
Email: steven.grunberg@uvm.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 17, 2013 |
| Modifications to this listing: |
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