|
||||||||||||||||||||||
|
|
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 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 Lead Organizations Memorial Sloan-Kettering Cancer Center
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. |
NCI Home |
Images Version |
Contact Us |
Policies |
Accessibility |
Viewing Files |
FOIA |
Site Help |
Site Map
|
A Service of the National Cancer Institute |