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A phase II study of constant‐infusion floxuridine for the treatment of metastatic renal cell carcinoma
Author(s) -
Wilkinson Mary J.,
Frye John W.,
Small Eric J.,
Venook Alan P.,
Carroll Peter R.,
Ernest Mary Lou,
Stagg Robert J.
Publication year - 1993
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(19930601)71:11<3601::aid-cncr2820711122>3.0.co;2-#
Subject(s) - floxuridine , medicine , renal cell carcinoma , chemotherapy , gastroenterology , carcinoma , urology , surgery , fluorouracil
Background . Twenty‐nine patients with metastatic renal cell carcinoma (RCC) were treated with constantinfusion 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.