Phase II study of cis-dichlorodiammineplatinum(II) (NSC-119875) in combination with cyclophosphamide (NSC-26271) in the treatment of human malignancies.

The effectiveness of cis-dichlorodiammineplatinum(II) in the treatment of human malignancies is evaluated. The first stage of our investigation consisted of a phase I study to determine toxicity. In the second stage attempts were made to reduce toxicity by varying the modes of administration, and the third stage comprised studies of combination chemotherapy including cis-dichlorodiammineplatinum(II). A total of 74 patients have been treated, 20 of whom received the combination of cis-dichlorodiammineplatinum(II) and cyclophosphamide. Major toxic effects included vomiting, mild leukopenia and thrombocytopenia, decreased creatinine clearance, audiologic toxic effects, hyperuricemia, and nephrotoxicity. Measurable regression of tumors was seen in 18 of the 74 patients and ten of the 18 patients who responded had been given the combination of cis-dichlorodiammineplatinum(ii) and cyclophosphamide.