Journal of Clinical Oncology, Vol 6, 98-105, Copyright © 1988 by American Society of Clinical Oncology
Phase II study of iproplatin in advanced ovarian carcinoma
C Sessa, J Vermorken, J Renard, S Kaye, D Smith, W ten Bokkel Huinink, F Cavalli and H Pinedo
Department of Oncology, Ospedale San Giovanni, Bellinzona, Switzerland.
Iproplatin (cis-dichloro-trans dihydroxy-bis-isopropyl-amine platinum [IV];
CHIP) was administered intravenously (IV) at monthly intervals at doses of
300 mg/m2 and 240 mg/m2 to ten previously untreated and 97 previously
treated patients with advanced ovarian carcinoma. The overall response rate
was 78% among patients with no prior chemotherapy, 42% among patients with
prior chemotherapy not including cisplatin, and 22% among patients with
prior chemotherapy including cisplatin. Overall response rates to
iproplatin were 6.4% and 54% in patients with/without clinical evidence of
tumor resistance to cisplatin. Thrombocytopenia was the dose-limiting
toxicity, median time to nadir and to recovery being 2 and 4 weeks,
respectively. Patients who had received prior chemotherapy regimens for
greater than 1 year showed a 10% greater reduction in platelet count (mean
platelet nadir +/- SD, 57.5 +/- 49.96 X 10(3)/microL) and a higher
incidence of grade 3 to 4 thrombocytopenia after the first cycle than
patients who had received prior chemotherapy regimens for less than 1 year
(94.7 +/- 65.99 X 10(3)/microL) Moderate to severe vomiting and diarrhea
occurred in 84% and 16% of patients pretreated with chemotherapy.
Neuropathy (6%) was reported only in patients with prior cisplatin
treatment. Mild and reversible renal toxicity was observed in 6% of cases.
Iproplatin is an active drug in ovarian cancer; the results achieved in
patients previously treated with cisplatin strongly suggest that the two
drugs are cross-resistant.
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