A phase II study of CHIP in advanced squamous cell carcinoma of the cervix (a Gynecologic Oncology Group Study).

The Gynecologic Oncology Group (GOG) conducted a Phase II trial of CHIP, cis-dichloro-trans-dihydroxy-bis-(isopropylamine)-platinum IV, in patients with measurable advanced squamous cell carcinoma of the cervix. No prior therapy with cytotoxic drugs was permitted in patients entered into this trial. All patients had a GOG performance status of 2 or better. CHIP at a starting dose of 230 mg/m2 was administered as a 30-minute IV infusion. Dose escalation was permitted to a maximum of 300 mg/m2. Treatments were repeated every four weeks until disease progressed or until toxicity prohibited further therapy. Thirty-six evaluable patients were entered between January and July, 1984. Of these, 34 were evaluable for response. Four complete and three partial responses were observed (response rate 20.6%). No neurotoxicity was noted and only mild and reversible nephrotoxicity was reported. Grade 3 gastrointestinal toxicity was reported in twenty patients (56%). Dose-limiting toxicity was myelosuppression. CHIP is an active agent against squamous cell carcinoma of the cervix and appears to be less neurotoxic and nephrotoxic than cisplatin. Gastrointestinal toxicity was moderate and appears equal to that seen with cisplatin at a dose of 50 mg/m2 given as a rapid IV infusion and more toxic than an equivalent dose of cisplatin administered over 24 hours. Randomized studies comparing CHIP and cisplatin are indicated to better define the relative therapeutic indices of these two compounds in the treatment of advanced squamous carcinoma of the cervix.