Phase II trial cisplatin, doxorubicin, and cyclophosphamide (CAP) in the treatment of urothelial transitional cell carcinoma.

Patients with advanced transitional cell cancer of the bladder, urethra, or renal pelvis were treated with a combination of cyclophosphamide, doxorubicin, and cisplatin. Fifteen patients were evaluated, 12 of whom had cancer of the urinary bladder. Metastatic sites were bone (47% of the patients); lung (33%) pelvis (27%); liver (20%); nodes (7%); and brain (7%). Only two patients (13%) achieved a partial response (in measurable node and lung lesions) and survived 16 and 58 weeks. Three patients (20%) had minor responses (in measurable bone, pelvis mass, and bone and local lesions) and survived 8, 28, 102+ weeks, respectively. Four patients had stable disease and six had disease progression, with a median survival of 4 weeks. Overall toxic effects were leukopenia (53% of the patients); thrombocytopenia (27%); nausea and vomiting (67%); alopecia (60%); and renal (13%). We concluded that the response rate to the combination of cyclophosphamide, doxorubicin, and cisplatin in transitional cell cancer of the urothelium was not superior to the reported response rate ot a single agent (eg, cisplatin), and toxicity was greater.