TY - JOUR
T1 - A phase I/II trial of cisplatin, docetaxel and ifosfamide in advanced or recurrent non-small cell lung cancer
AU - Kunitoh, Hideo
AU - Akiyama, Yoshiko
AU - Kusaba, Hitoshi
AU - Yamamoto, Noboru
AU - Sekine, Ikuo
AU - Ohe, Yuichiro
AU - Kubota, Kaoru
AU - Tamura, Tomohide
AU - Shinkai, Tetsu
AU - Kodama, Tetsuro
AU - Goto, Koichi
AU - Niho, Seiji
AU - Nishiwaki, Yutaka
AU - Saijo, Nagahiro
N1 - Funding Information:
Presented in part at the 35th Annual Meeting of the American Society of Clinical Oncology, Atlanta, GA, May 15–18, 1999. Supported in part by the Grant-in-Aid for Cancer Research (9–25) from the Ministry of Health and Welfare, Tokyo, Japan. Supported in part by a grant-in-aid for Cancer Research from the Ministry of Health and Welfare, Japan.
PY - 2001
Y1 - 2001
N2 - This trial was initiated to evaluate the toxicity and activity of combination chemotherapy employing cisplatin (CDDP), docetaxel (DCT) and ifosfamide (IFX) in non-small cell lung cancer (NSCLC), and to determine the maximum tolerated dose (MTD) of IFX. Chemotherapy-naive patients with advanced or recurrent NSCLC received 60 mg/m2 DCT followed after a 3-h interval by 60 mg/m2 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. Granulocyte colony-stimulating factor (GCSF) was administered in the event of grade 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 evaluate the toxicity of the drugs around the MTD. Level 5 was also judged as having exceeded the MTD, with febrile neutropenia and hepatic toxicity being observed as the dose-limiting toxicities. No toxicity-related deaths occurred. The majority of the chemotherapy courses were supported by GCSF administration. A total of 33 eligible patients were entered into the trial; the overall response rate was10/33 or 30% among all eligible cases, and the rate 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/m2 administered for 3 days in this triplet combination. The clinical activity does not seem to justify the toxicity profile.
AB - This trial was initiated to evaluate the toxicity and activity of combination chemotherapy employing cisplatin (CDDP), docetaxel (DCT) and ifosfamide (IFX) in non-small cell lung cancer (NSCLC), and to determine the maximum tolerated dose (MTD) of IFX. Chemotherapy-naive patients with advanced or recurrent NSCLC received 60 mg/m2 DCT followed after a 3-h interval by 60 mg/m2 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. Granulocyte colony-stimulating factor (GCSF) was administered in the event of grade 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 evaluate the toxicity of the drugs around the MTD. Level 5 was also judged as having exceeded the MTD, with febrile neutropenia and hepatic toxicity being observed as the dose-limiting toxicities. No toxicity-related deaths occurred. The majority of the chemotherapy courses were supported by GCSF administration. A total of 33 eligible patients were entered into the trial; the overall response rate was10/33 or 30% among all eligible cases, and the rate 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/m2 administered for 3 days in this triplet combination. The clinical activity does not seem to justify the toxicity profile.
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U2 - 10.1016/S0169-5002(01)00189-1
DO - 10.1016/S0169-5002(01)00189-1
M3 - Article
C2 - 11551421
AN - SCOPUS:0034900354
SN - 0169-5002
VL - 33
SP - 259
EP - 265
JO - Lung Cancer
JF - Lung Cancer
IS - 2-3
ER -
