title: Phase I study of adozelesin (U-73,975) in patients with solid tumors.
abstract: During a phase I clinical and pharmacologic trial, 26 patients with refractory solid tumors were treated with increasing doses of adozelesin by brief intravenous infusion every 3 weeks. Overall, adozelesin was well tolerated. The dose-limiting toxicity was myelosuppression, mainly thrombocytopenia and leukopenia. Nonhematologic toxicity was generally mild, with fatigue (36%), local reaction at the infusion site (24%), nausea or vomiting (20%) and hypersensitivity reaction (16%) being the most common adverse effects. There were no objective clinical responses. The maximally tolerated dose on this schedule was 188 micrograms/m2 with the recommended phase II starting dose being 150 micrograms/m2 on an every 3 week schedule. Adozelesin merits broad investigation at the phase II level.
authors.affiliation: Department of Internal Medicine, University of Arizona, Tucson 85724.
authors.forename: G J
authors.initials: GJ
authors.lastname: Shamdas
authors.forename: D S
authors.initials: DS
authors.lastname: Alberts
authors.forename: M
authors.initials: M
authors.lastname: Modiano
authors.forename: C
authors.initials: C
authors.lastname: Wiggins
authors.forename: J
authors.initials: J
authors.lastname: Power
authors.forename: D A
authors.initials: DA
authors.lastname: Kasunic
authors.forename: G L
authors.initials: GL
authors.lastname: Elfring
authors.forename: R H
authors.initials: RH
authors.lastname: Earhart
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001572:Benzofurans; D003509:Cyclohexanecarboxylic Acids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D053138:Cyclohexenes; D004351:Drug Resistance; D000080890:Duocarmycins; D005260:Female; D006801:Humans; D007211:Indoles; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*
chemical_list: D000970:Antineoplastic Agents; D001572:Benzofurans; D003509:Cyclohexanecarboxylic Acids; D053138:Cyclohexenes; D000080890:Duocarmycins; D007211:Indoles; C060090:adozelesin