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A phase II study of constant-infusion floxuridine for the treatment of metastatic renal cell carcinoma.

AbstractBACKGROUND:
Twenty-nine patients with metastatic renal cell carcinoma (RCC) were treated with constant-infusion floxuridine (FUdR, Roche Laboratories, Nutley, NJ).
METHODS:
The initial dosage was 0.075 mg/kg/day for 14 days every 28 days and was increased or decreased by 0.025-mg/kg/day increments at each subsequent cycle until the maximum tolerated dose (MTD) was achieved.
RESULTS:
All patients were fully assessable. One (4%) patient had a complete response, 5 (17%) had a partial response, 13 (50%) had stabilized disease, and 10 (34%) had progressive disease. The treatment-limiting toxic effect was diarrhea, and the median tolerated dosage was 0.1 mg/kg/day for 14 days every 28 days (range, 0.05-0.275 mg/kg/day). Five of the six responses occurred at a dosage of 0.1 mg/kg/day or less, which was achievable in most patients. Patients who reached their MTD without achieving a complete or partial response were switched to circadian-infusion floxuridine to determine whether an increased dose intensity could be administered and whether this would translate into additional responses. A higher median tolerated dosage of 0.15 mg/kg/day was achieved with circadian administration; however, no additional responses were observed. The median survival time was 891 days after the diagnosis of metastatic RCC and 445 days after the institution of floxuridine therapy.
CONCLUSIONS:
Constant-infusion floxuridine is active against metastatic RCC and produces a response rate that appears to be comparable to that of circadian administration of floxuridine.
AuthorsM J Wilkinson, J W Frye, E J Small, A P Venook, P R Carroll, M L Ernest, R J Stagg
JournalCancer (Cancer) Vol. 71 Issue 11 Pg. 3601-4 (Jun 01 1993) ISSN: 0008-543X [Print] United States
PMID8490909 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article)
Chemical References
  • Floxuridine
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Carcinoma, Renal Cell (drug therapy, secondary)
  • Circadian Rhythm
  • Diarrhea (chemically induced)
  • Drug Administration Schedule
  • Female
  • Floxuridine (administration & dosage, adverse effects)
  • Humans
  • Infusion Pumps, Implantable
  • Infusions, Intravenous
  • Kidney Neoplasms (drug therapy)
  • Male
  • Middle Aged

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