Phase I study of intravenous fosquidone (GR63178A-NSC D611615) using a three times a week schedule.
In a Phase I study fosquidone was administered to 23 patients (15 female, 8 male; mean age 53.6 years) with various solid tumours. Increasing doses (50-325 mg/m2) were given intravenously three times a week for 3 weeks. The MTD was established a 325 mg/m2 dose, the dose limiting factor being phlebitis in two of three patients. The other main side-effects were headache (9 patients), pain (11 patients) and nausea and vomiting (16 patients). The majority of these were mild (WHO grade 1-2), but two patients reported WHO grade 3 and 4 pain. There was no clear relationship between dose, severity and frequency of side-effects. Four tumour regressions (three minor and one partial response) were achieved at varying dose levels (50, 100, 160 and 325 mg/m2) in patients with different tumours (laryngeal, colorectal and lung). The recommended dose for Phase II studies is 250 mg/m2 given intravenously three times a week for 3 week.
Planting
A S
AS
Department of Medical Oncology, Rotterdam Cancer Institute, The Netherlands.
van der Burg
M E
ME
Stoter
G
G
Beranek
P
P
Verweij
J
J
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002985:Clinical Protocols; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D005260:Female; D006261:Headache / Q000139:chemically induced; D006801:Humans; D007275:Injections, Intravenous; D007546:Isoquinolines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009369:Neoplasms / Q000188:drug therapy*; D009943:Organophosphorus Compounds; D010146:Pain; D010689:Phlebitis / Q000139:chemically induced; D012074:Remission Induction; D014839:Vomiting / Q000139:chemically induced
D000970:Antineoplastic Agents; D007546:Isoquinolines; D009943:Organophosphorus Compounds; C072687:fosquidone