title: Paclitaxel plus gallium nitrate and filgrastim in patients with refractory malignancies: a phase I trial.
abstract: To determine the maximally tolerated dose of paclitaxel with and without filgrastim (G-CSF) when administered as a 24-hour intravenous infusion after a 120-hour infusion of gallium nitrate at a fixed dose of 300 mg/m2/24 hours, 40 patients were entered onto a trial lasting from September 1994 to September 1996. Eligibility included a diagnosis of an advanced malignancy not amenable to curative therapy and up to one previous chemotherapy regimen for metastatic disease. Gallium was administered at a fixed dose of 300 mg/m2/day as a continuous intravenous infusion for 120 hours. Paclitaxel starting at 90 mg/m2 was given concurrently with the last 24 hours of the gallium as a 24-hour intravenous infusion. Cycles were repeated every 21 days. Once the maximum tolerated dose (MTD) of paclitaxel was reached, G-CSF (5 microg/kg/day days 7-16) was added and paclitaxel dose escalation continued. The MTD for paclitaxel without G-CSF was 110 mg/m2 and 225 mg/m2 with G-CSF, with neutropenia being the dose-limiting toxicity. A partial response was noted in a patient who had thymoma and a complete response was achieved in a patient who had colon cancer. The recommended phase II dosage is gallium nitrate at 300 mg/m2/day over 120 hours, with paclitaxel at 110 mg/m2 over 24 hours without G-CSF or 225 mg/m2 over 24 hours with G-CSF and 0.5 mg calcitriol on days 1 through 7. Further trials of this modified regimen for outpatient administration are in progress.
authors.affiliation: Division of Hematology/Oncology, Indiana University, Indianapolis, USA.
authors.forename: A
authors.initials: A
authors.lastname: Sandler
authors.forename: S
authors.initials: S
authors.lastname: Fox
authors.forename: T
authors.initials: T
authors.lastname: Meyers
authors.forename: A
authors.initials: A
authors.lastname: Christou
authors.forename: G
authors.initials: G
authors.lastname: Weber
authors.forename: R
authors.initials: R
authors.lastname: Gonin
authors.forename: P J
authors.initials: PJ
authors.lastname: Loehrer
authors.forename: L H
authors.initials: LH
authors.lastname: Einhorn
authors.forename: R
authors.initials: R
authors.lastname: Dreicer
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D000069585:Filgrastim; D005708:Gallium / Q000008:administration & dosage; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D011994:Recombinant Proteins
chemical_list: D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D005708:Gallium; D017239:Paclitaxel; D000069585:Filgrastim; C027235:gallium nitrate