Phase II evaluation of cis-dichlorodiammineplatinum(II) in advanced malignancies of the genitourinary and gynecologic organs: a Southwest Oncology Group Study.

One hundred and forty-seven fully and partially evaluable patients with advanced measurable malignancies of the genitourinary and gynecologic organs were given cis-dichlorodiammineplatinum(II) at a dose of 75 mg/m2 iv every 3 weeks. Thirty-six patients with testicular neoplasms were studied; five complete responses (13.9%) and seven partial responses (PR) (19.4%) were noted. Thirty-seven patients with ovarian adenocarcinoma were evaluated; five PRs (13.5%) were seen. One complete response (11.1%) and two PRs (22.2%) were obtained among nine patients with urinary bladder cancer. Four PRs (19.0%) were seen among a group of 21 patients with advanced prostate cancer. One PR (4.8%) was noted among 21 patients with renal cell cancer and no responses were seen in eight patients with cervical cancer. There was a highly statistically significant (P less than 0.001) survival advantage for the responding testicular tumor patients. Toxicity was similar to that previously reported, with gastrointestinal side effects and nephrotoxicity most commonly seen. Prospective and sequential analysis of renal function provided strong evidence for cumulative nephrotoxicity in these patients given bolus injections of cis-dichlorodiammineplatinum(II) without prehydration or treatment with fuosemide or mannitol.