Activity and toxicity of GI147211 in breast, colorectal and non-small-celllung cancer patients: An EORTC-ECSG phase II clinical study

Citation
T. Gamucci et al., Activity and toxicity of GI147211 in breast, colorectal and non-small-celllung cancer patients: An EORTC-ECSG phase II clinical study, ANN ONCOL, 11(7), 2000, pp. 793-797
Citations number
14
Categorie Soggetti
Oncology,"Onconogenesis & Cancer Research
Journal title
ANNALS OF ONCOLOGY
ISSN journal
09237534 → ACNP
Volume
11
Issue
7
Year of publication
2000
Pages
793 - 797
Database
ISI
SICI code
0923-7534(200007)11:7<793:AATOGI>2.0.ZU;2-2
Abstract
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 pat ients with pretreated breast cancer (25 patients) and chemo-naive colorecta l (19 patients) and nonsmall-cell lung cancer (23 patients) were entered in to three multicentric, non-randomized phase II trials. Treatment schedule c onsisted of intravenous GI147211 administered at a dose of 1.2 mg/m(2)/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 infecti on in 14.5% of patients. Grade 3-4 thrombocytopenia and grade 2-4 anemia we re observed in 20% and in 68% of patients, respectively. Nonhematological t oxicity was generally mild to moderate and consisted mainly of gastrointest inal toxicity, asthenia and alopecia. A dose-escalation to 1.5 mg/m(2)/d wa s feasible in 17 (25%) patients. The antitumor activity of GI147211 was mod erate 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, sho wed an acceptable safety profile but a modest antitumor activity in the exa mined tumor types.