A Phase I/II Study of Topotecan in Combination with Carboplatin in Recurrent Epithelial Ovarian Cancer
Articolo
Data di Pubblicazione:
2001
Citazione:
A Phase I/II Study of Topotecan in Combination with Carboplatin
in Recurrent Epithelial Ovarian Cancer / G. Bolis, G. Scarfone, C. Sciatta, G.P. Polverino, C. Rosa, P. Guarnerio, F. Parazzini. - In: GYNECOLOGIC ONCOLOGY. - ISSN 0090-8258. - 83:3(2001 Dec), pp. 477-480. [10.1006/gyno.2001.6399]
Abstract:
Objective. The purpose of this study was to define the maximum
tolerated dose (MTD) of topotecan given as escalating doses combined
to a fixed dosage of carboplatin in late relapsing ovarian
carcinomas.
Methods. Women with relapsing ovarian cancer more than 6
months after first-line treatment were eligible for the study. In the
first phase of the trial, patients were allocated to escalating topotecan
doses with a carboplatin fixed dose (AUC 5, according to
Cockcroft’s formula). If no “severe” adverse event occurred in 1 or
more of the patients, the topotecan dose was increased. The starting
dose of topotecan was 0.50 mg/m2/day, for 3 consecutive days,
and the dose step was of 0.25 mg/m2/day, till 1.5 mg/m2/day. The
study progressed then in a phase II trial.
Results. A total of 39 patients entered the trial. Twenty took
part in the escalating topotecan dose phase (4 per dose level, 0.50,
0.75, 1, 1.25, and 1.50 mg/m2/day) and 19 in the phase II. No
severe adverse event was observed in the phase I of the trial, so the
MTD was not reached. In the phase II trial topotecan was given to
1 mg/m2/day. Overall grade 3–4 neutropenia, lasting 7 days or less,
was observed in 58.9% (23 patients). Thrombocytopenia occurred
in 30.8% (12 patients) and grade 3 anemia in 25.6% (10 patients)
of subjects. No life-threatening event occurred. Platelets or red
blood cell transfusions were given in three cases (7.8%).
Conclusions. This daily-times-3-day schedule of topotecan in
combination with carboplatin is safe.
Tipologia IRIS:
01 - Articolo su periodico
Keywords:
ovarian cancer ; topotecan ; carboplatin; treatment
Elenco autori:
G. Bolis, G. Scarfone, C. Sciatta, G.P. Polverino, C. Rosa, P. Guarnerio, F. Parazzini
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