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Antiemetic Therapy with Levonantradol vs Prochlorperazine for Cancer Patients Receiving Nausea-Inducing Chemotherapy
Basic Trial Information
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 Lead Organizations University of Wisconsin Paul P. Carbone Comprehensive 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. |
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