Activity and toxicity of GI147211 in breast, colorectal and non-small-cell lung cancer patients: An EORTC-ECSG phase II clinical study
Date
2000Author
Gamucci, T.Paridaens, R.
Heinrich, B.
Schellens, J. H. M.

Verweij, J.
Sessa, Cristiana
Kaye, Stanley B.
Roelvink, M.
Wanders, J.
Hanauske, A. R.
Source
Annals of OncologyVolume
11Issue
7Pages
793-797Google Scholar check
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Background: GI147211 is a water-soluble synthetic analogue of camptothecin showing promising in vivo and in vitro antitumor activity and an acceptable toxicity profile. Patients and methods: Between April 1995 and November 1996, 67 eligible patients with pretreated breast cancer (25 patients) and chemo-naive colorectal (19 patients) and non-small-cell lung cancer (23 patients) were entered into three multicentric, non-randomized phase II trials. Treatment schedule consisted of intravenous GI147211 administered at a dose of 1.2 mg/m2/day for five consecutive days every three weeks. Results: Hematological toxicity was common with grade 3-4 neutropenia in 54% of patients and neutropenic fever together or not associated with infection in 14.5% of patients. Grade 3-4 thrombocytopenia and grade 2-4 anemia were observed in 20% and in 68% of patients, respectively. Non-hematological toxicity was generally mild to moderate and consisted mainly of gastrointestinal toxicity, asthenia and alopecia. A dose-escalation to 1.5 mg/m2/d was feasible in 17 (25%) patients. The antitumor activity of GI147211 was moderate in breast cancer patients (3 partial responses (PRs), response rate (RR) 13%) and minimal in non-small cell lung cancer patients (2 PRs, RR 9%). No objective responses were obtained in colorectal patients. Conclusions: GI147211, at the dose and schedule employed in this study, showed an acceptable safety profile but a modest antitumor activity in the examined tumor types.
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