A Phase II Evaluation of a 3-Drug Combination of Cyclophosphamide, Doxorubicin and 5-Fluorouracil and of 5-Fluorouracil in Patients with Advanced Bladder Carcinoma or Stage D Prostatic Carcinoma

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Abstract
The Southeastern Cancer Study Group [USA] evaluated 5-fluorouracil [FU] administered i.v. weekly at a dosage of 600 mg/m2 as a single agent, and the 3 drug combination of cyclophosphamide [CP], doxorubicin [DX] and FU in patients with metastatic carcinoma of the bladder and of the prostate previously untreated with cytotoxic chemotherapy in a prospectively randomized phase II study. In 4 of 18 patients with bladder carcinoma FU induced an objective response. CP, DX and FU induced an objective response in 3 of 21 patients. In patients with prostatic carcinoma FU induced an objective response as measured by a 50% decrease in prostatic acid phosphatase determined in a central reference laboratory in 3 of 25 patients and objective stability by the National Prostatic Cancer Project criteria in 14 of 29 patients. CP, DX and FU induced an objective response in 7 of 22 patients and objective stability in 20 of 29. FU administered in an adequate weekly dosage is established as an effective single agent in some patients with stage D carcinoma of the bladder or prostate. There is no significant added benefit as measured by survival obtained for these patients by combining CP and DX with FU.