Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Chemotherapy-induced Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

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


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).

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Number of Participants with Total protection

Outcome Description:

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.

Outcome Time Frame:

5 Days (first 5 days of the first cycle of chemotherapy)

Safety Issue:

No

Principal Investigator

Steven M. Grunberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Vermont

Authority:

United States: Federal Government

Study ID:

2006-0841

NCT ID:

NCT00553059

Start Date:

October 2007

Completion Date:

Related Keywords:

  • Chemotherapy-Induced Nausea and Vomiting
  • Unspecified Adult Solid Tumor, Protocol Specific
  • nausea and vomiting
  • unspecified adult solid tumor
  • Palonosetron
  • Dexamethasone
  • Nausea
  • Vomiting

Name

Location

Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - GreenvilleGreenville, South Carolina  29615
Vermont Cancer Center at University of VermontBurlington, Vermont  05405-0075
University of Texas M.D. Anderson CCOP Research BaseHouston, Texas  77030-4009