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	18 to 70		UKMC-87GYN03 NCI-V88-0455

Objectives

I.  Determine the efficacy of a rectal suppository containing metoclopramide, 
dexamethasone, and diphenhydramine in the treatment of chemotherapy-induced 
nausea and vomiting.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients 18 to 70 years of age who 
have been admitted to the University of Kentucky Medical Center, Lucille 
Parker Markey Cancer Center, or the Medical Plaza for treatment of a 
malignancy by single or combination chemotherapy protocols containing 
cisplatin.

Expected Enrollment

16 patients will be randomly assigned to each of study arms; if the number of 
successes on the treatment arm exceeds the number of successes on the placebo 
arm by at least 6 or if the number of successes on the treatment arm is the 
same or less than the number of successes on the placebo arm, the trial will 
be stopped.  If the number of successes on the treatment arm exceeds the 
number of successes on the placebo arm by less than 6, 16 additional patients 
will be randomly assigned to each of these study arms.

Outline

Randomized study.  Patients receive treatment on Regimen A and are randomized 
to Arms I and II.
Regimen A:  Antiemetic Therapy.  Lorazepam; Diphenhydramine; Dexamethasone, 
DM, NSC-34521; Metoclopramide, MCP.
Arm I:  No Additional Antiemetic Therapy.  Placebo rectal suppository.
Arm II:  Antiemetic Therapy.  Rectal suppository containing MCP, DM, and 
Diphenhydramine.

Trial Contact Information

Trial Lead Organizations

Lucille P. Markey Cancer Center at University of Kentucky

Holly Gallion, MD, Protocol chair(Contact information may not be current)		Ph: 859-257-4500