title: A dose-finding study of the weekly administration of paclitaxel in patients with advanced solid tumors.
abstract: The purpose of this study was to determine the dose-limiting toxicities and the maximum-tolerated dose (MTD) of weekly administration of paclitaxel in patients with advanced solid tumors. Twenty-six patients with advanced solid tumors were treated with escalated doses of paclitaxel (starting dose 70 mg/m(2)/wk with increments of 10 mg/m(2)/wk) for 4 consecutive weeks every 6 weeks. No intrapatient escalation or growth factor support was allowed. The DLT was exceeded at the dose of 120 mg/m(2)/wk, and the dose-limiting events were grade IV neutropenia and treatment delay because of incomplete hematologic recovery. There was no cumulative myelosuppression. Grade IV neutropenia occurred in four (6%) cycles, and there was one episode of febrile neutropenia. Grade II/III fatigue occurred in 19 (73%) patients, resulting in discontinuation of treatment in 2 of them; grade II neurosensory toxicity and grade II alopecia occurred in 8 (31%) patients each. The MTD, which is also the recommended dose for further phase II studies, was 110 mg/m(2)/wk. Among the 21 patients with bidimensionally measurable disease, 2 (10%) partial responses were observed, both in patients with heavily pretreated advanced breast cancer. The weekly administration of paclitaxel for 4 consecutive weeks in cycles of 6 weeks is a feasible, safe, and active outpatient regimen that merits further evaluation in combination with other anticancer agents.
authors.affiliation: Department of Medical Oncology, University General Hospital of Heraklion, Heraklion, Crete, Greece.
authors.forename: C
authors.initials: C
authors.lastname: Kouroussis
authors.forename: S
authors.initials: S
authors.lastname: Kakolyris
authors.forename: D
authors.initials: D
authors.lastname: Mavroudis
authors.forename: N
authors.initials: N
authors.lastname: Androulakis
authors.forename: K
authors.initials: K
authors.lastname: Kalbakis
authors.forename: S
authors.initials: S
authors.lastname: Agelaki
authors.forename: E
authors.initials: E
authors.lastname: Sarra
authors.forename: J
authors.initials: J
authors.lastname: Souglakos
authors.forename: M
authors.initials: M
authors.lastname: Christodoulakis
authors.forename: G
authors.initials: G
authors.lastname: Samonis
authors.forename: V
authors.initials: V
authors.lastname: Georgoulias
mesh_terms: D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000627:therapeutic use; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy; D009503:Neutropenia; D017239:Paclitaxel / Q000008:administration & dosage* / Q000627:therapeutic use
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel