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KMID : 0358419920350040571
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Korean Journal of Obstetrics and Gynecology
1992 Volume.35 No. 4 p.571 ~ p.588
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Phase I Clinical Trial of Simultaneous Administration of Intraperitoneal Carboplatin, Etoposide and Cytosine Arabinoside for Refractory Ovarian Carcinoma
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Abstract
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Thirteen patients of ovarian carcinoma who failed after intravenous cisplatin based combination chemotherapy were treated with simultaneous intraperitoneal carboplatin, etoposide and cytosine arabinoside.
The study subjects comprised 11 cases of epithelial ovarian carcinoma and two cases of malignant germ cell tumor of the ovary, i.e., one was endodermal sinus tumor and the other was grade III immature teratoma.
They were administered a fixed dose of 250 mg/ml carboplatin along with a starting dose of 50 mg/m´, etoposide and 750 mg, cytosine arabinoside respectively, both of which were escalated at each consecutive courses up to 300 mg/m2 and 2000 mg depending on the toxicities that could be tolerated. The maintenance doses were adjusted individually according to the adverse reactions and the performance status. Dose limiting toxicity was the myelosupression and the gastrointestinal upset was the primary toxicity encountered. Maximum tolerated dose was determined to be 250 mg of etoposide and 1750 mg of cytosine arabinoside when in fixed dosage of carboplatin. Probably due to previous heavy treatment with cytotoxic drugs, marrow recovery was delayed in 24 courses (32.9 %), which enabled us to fix the 4 week interval treatment schedule. There were no drug related death or interrution of treatment, but one patient refused further scheduled treatment and out of 12 patients who had completed treatment courses, 7 patients (58.3 %) achieved clinical complete response and 3 patients (25.0 %) had clinical partial response. 2 patients had progressive disease. Of all patients whoattained the clinical complete response underwent second and third look laparotomy, 4 patients (33.3 %) including 2 cases of grem cell tumor had surgical pathologic complete response, all of whom have been still alive for more than 19 months.
The favorable pharmacokinetic synergism of the drugs administered in this study renders it worthwhile to pursue further clinical trial.
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