A phase I/II trial of cisplatin, docetaxel and ifosfamide in advanced or recurrent non-small cell lung cancer

Citation
H. Kunitoh et al., A phase I/II trial of cisplatin, docetaxel and ifosfamide in advanced or recurrent non-small cell lung cancer, LUNG CANC, 33(2-3), 2001, pp. 259-265
Citations number
23
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Oncology
Journal title
LUNG CANCER
ISSN journal
0169-5002 → ACNP
Volume
33
Issue
2-3
Year of publication
2001
Pages
259 - 265
Database
ISI
SICI code
0169-5002(200108/09)33:2-3<259:APITOC>2.0.ZU;2-U
Abstract
This trial was initiated to evaluate the toxicity and activity of combinati on chemotherapy employing cisplatin (CDDP), docetaxel (DCT) and ifosfamide (IFX) in non-small cell lung cancer (NSCLC), and to determine the maximum t olerated dose (MTD) of IFX. Chemotherapy-naive patients with advanced or re current NSCLC received 60 mg/m(2) DCT followed after a 3-h interval by 60 m g/m(2) CDDP on chemotherapy day 1, and IFX at an escalating dose with mesna protection on days 2-4. The chemotherapy was repeated every 3 weeks. Granu locyte colony-stimulating factor (GCSF) was administered in the event of gr ade 3 leukopenia/neutropenia. The patients tolerated the treatment well up to level 4 of IFX dosing 1.5 g/day, but not the IFX dose at level 6 (2.0 g/ day). Additional patients were enrolled in level 5 (IFX 1.7 g/day) to evalu ate the toxicity of the drugs around the MTD. Level 5 was also judged as ha ving exceeded the MTD, with febrile neutropenia and hepatic toxicity being observed as the dose-limiting toxicities. No toxicity-related deaths occurr ed. The majority of the chemotherapy courses were supported by GCSF adminis tration. A total of 33 eligible patients were entered into the trial; the o verall response rate was 10/33 or 30% among all eligible cases, and the rat e for patients treated with the MTD or higher (levels 4-6) was 8/24, or 33% (90% confidence limit: 18-52%). The MTD of IFX was 1.5 g/m(2) administered for 3 days in this triplet combination. The clinical activity does not see m to justify the toxicity profile. (C) 2001 Elsevier Science Ireland Ltd. A ll rights reserved.