[Phase II study on cis-diamminedichloroplatinum (II) by a collaborative study]

Phase II study of cis-diaminedichloroplatinum(II) (CIS-DDP) administered intravenously was performed in 77 patients with urologic malignancies for the evaluation of clinical responses and adverse effects. The eligibility of the patients and evaluation of response were carried out according to the general criteria proposed by Drs. Koyama and Saito. Out of 85 patients, entered in this phase II study, 77 patients were considered evaluable. Complete responses were seen in 4 patients, 3 testicular tumor and 1 bladder cancer. Partial response were obtained in 24 patients; 10 bladder cancer, 8 testicular tumor, 5 prostatic cancer, and 1 renal cell carcinoma. Overall response rates were 73.3% in testicular tumor, 50.0% in bladder tumor, 20.8% in prostatic cancer, and 7.7% in renal cell carcinoma. Incidences of toxicities were noted in the gastrointestinal tract. Nausea, vomiting, anorexia, abdominal pain, and diarrhea were observed in 78.5% of the patients treated with CIS-DDP. Myelosuppression, lassitude, renal and hearing dysfunction were other prominent adverse effects.