Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Supportive care	Closed	16 to 80		WCCC-CO-8096

Objectives

I.  Compare the objective and subjective efficacies of levonantradol and 
prochlorperazine as intramuscular antiemetic agents in patients receiving 
specific single- or multiple-drug cancer chemotherapeutic regimens.
II.  Correlate the antiemetic effect with blood levels of the antiemetic 
agents.
III.  Observe all patients for objective and subjective toxic effects of the 
antiemetic agents and compare the toxicities of levonantradol and 
prochlorperazine.
IV.  Compare patient acceptance of these agents as antiemetic therapy.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients between the ages of 16 and 
80 who are being treated for cancer on selected EST and CO protocols.  
Patients must have an ECOG performance status of 0, 1, 2, or 3 and adequate 
general medical status (hepatic, renal, and coagulation status).  There must 
be no history of allergy or severe reactions to phenothiazines or 
cannabinoids.  Patients must have no significant history of psychotic 
episodes; they must not be receiving chronic narcotics or phenothiazines.

Expected Enrollment

12 to 40 patients from each chemotherapy regimen will be required.  Protocol 
closed.

Outline

Randomized, double-blind study.  Patients are concurrently treated on one of 
the following protocols:  EST-1675, EST-1877, EST-3878, EST-3477, EST-4477, 
EST-2278, EST-3278, EST-5275, EST-1377, EST-1379, EST-3377, EST-2878, 
EST-2879, EST-PC879, or Wisconsin Clinical Cancer Center (WCCC) protocols 
CO-7882, CO-7881, CO-8093, CO-8094, or CO-8095.
Arm I:  Alternating Single-agent Antiemetic Therapy.  Levonantradol, 
NSC-331615 with the first cycle of Chemotherapy; Prochlorperazine with the 
second cycle.
Arm II:  Alternating Single-agent Antiemetic Therapy.  Prochlorperazine with 
the first cycle of Chemotherapy; Levonantradol with the second cycle.

Trial Contact Information

Trial Lead Organizations

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Paul Carbone, MD, Protocol chair(Contact information may not be current)		Ph: 608-265-8047; 800-622-8922 Email: carbone@biostat.wisc.edu