Phase I study of adozelesin (U-73,975) in patients with solid tumors.
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.
Shamdas
G J
GJ
Department of Internal Medicine, University of Arizona, Tucson 85724.
Alberts
D S
DS
Modiano
M
M
Wiggins
C
C
Power
J
J
Kasunic
D A
DA
Elfring
G L
GL
Earhart
R H
RH
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*
D000970:Antineoplastic Agents; D001572:Benzofurans; D003509:Cyclohexanecarboxylic Acids; D053138:Cyclohexenes; D000080890:Duocarmycins; D007211:Indoles; C060090:adozelesin