title: Phase I study of Datelliptium chloride, hydrochloride given by 24-h continuous intravenous infusion.
abstract: Datelliptium chloride, hydrochloride (SR 95 156B, NSC 626718X, DHE) was studied in a phase I trial of escalating doses given on a single 24-h continuous intravenous infusion schedule. Doses were escalated from 40 to 500 mg/m2 in 19 patients who received a total of 24 courses. Courses were repeated after a minimal interval of 3 weeks. Local venous toxicity occurred at low doses (less than or equal to 100 mg/m2) and was circumvented by the use of a central venous access for higher doses. Other clinical adverse events occurred (greater than or equal to 330 mg/m2), including moderate nausea and vomiting, mild diarrhea, dry mouth, neuropsychiatric manifestations, and fatigue. All of these side effects were reversible and none was dose-limiting. The dose-limiting toxicity was related to hepatic laboratory-test abnormalities in the form of reversible elevations of levels of serum bilirubin and liver enzymes at doses of greater than or equal to 330 mg/m2. The maximum tolerated dose for this schedule is 500 mg/m2. Hematologic toxicity was minimal and non-dose-limiting. Neither drug-related deaths nor objective complete or partial responses were observed. However, a minor response and a long-term disease stabilization were obtained.
authors.affiliation: Medical Oncology Unit, Hôpital La Pitié-Salpétrière, Paris, France.
authors.forename: D
authors.initials: D
authors.lastname: Khayat
authors.forename: C
authors.initials: C
authors.lastname: Borel
authors.forename: M
authors.initials: M
authors.lastname: Azab
authors.forename: D
authors.initials: D
authors.lastname: Paraisot
authors.forename: E
authors.initials: E
authors.lastname: Malaurie
authors.forename: C
authors.initials: C
authors.lastname: Bouloux
authors.forename: M
authors.initials: M
authors.lastname: Weil
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004341:Drug Evaluation; D004611:Ellipticines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*
chemical_list: D000970:Antineoplastic Agents; D004611:Ellipticines; C060073:detalliptinium