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	Maintenance Rituximab for Follicular Lymphoma Azacitidine Improves Survival in MDS Second Stem Cell Transplant Not Helpful in Myeloma

Phase I/II Study of Escalating Single Doses of Metoclopramide Given in Combination with Dexamethasone and Lorazepam for the Control of Cisplatin-Induced Nausea and Vomiting (Summary Last Modified 02/91)

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II, Phase I Supportive care Completed 30 and over MSKCC-88074
NCI-V88-0580

Objectives

I.  Determine the side-effects associated with high single doses of 
metoclopramide when given with fixed doses of dexamethasone and lorazepam.
II.  Estimate the antiemetic efficacy of this regimen when given prior to 
cisplatin chemotherapy.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients at least 30 years of age 
with pathologically documented malignancies who are receiving cisplatin at a 
dose of at least 100 mg/sqm, provided no nausea or vomiting is experienced in 
the 24 hours preceding chemotherapy.  High doses of cyclophosphamide or 
dacarbazine in addition to the cisplatin are not allowed.  Patients with known 
sensitivity to benzodiazepines, metoclopramide, or dexamethasone are excluded. 
 Karnofsky performance status must be at least 60%, and adequate hematologic, 
hepatic, and renal function must be demonstrated (WBC at least 3,000, 
platelets at least 75,000, bilirubin and creatinine each no greater than 1.5 
mg/dl, and creatinine clearance at least 60 ml/minute).  Arrhythmia, 
uncontrolled angina, clinical evidence of congestive heart failure, gastric 
outlet obstruction, and pregnancy exclude.

Expected Enrollment

At least 63 patients will be studied.

Outline

Nonrandomized study.
3-Drug Antiematic Therapy.  Metoclopramide; Lorazepam; Dexamethasone, DM, 
NSC-34521.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Mark Kris, MD, Protocol chair
Ph: 212-639-7590; 800-525-2225

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.