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

Hideo Kunitoh, Yoshiko Akiyama, Hitoshi Kusaba, Noboru Yamamoto, Ikuo Sekine, Yuichiro Ohe, Kaoru Kubota, Tomohide Tamura, Tetsu Shinkai, Tetsuro Kodama, Koichi Goto, Seiji Niho, Yutaka Nishiwaki, Nagahiro Saijo

Research output: Contribution to journalArticle

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Abstract

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.

Original languageEnglish
Pages (from-to)259-265
Number of pages7
JournalLung Cancer
Volume33
Issue number2-3
DOIs
Publication statusPublished - Aug 15 2001
Externally publishedYes

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docetaxel
Ifosfamide
Maximum Tolerated Dose
Non-Small Cell Lung Carcinoma
Cisplatin
Drug Therapy
Granulocyte Colony-Stimulating Factor
Mesna
Febrile Neutropenia
Leukopenia
Combination Drug Therapy
Neutropenia
Drug-Related Side Effects and Adverse Reactions
Liver

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

Cite this

A phase I/II trial of cisplatin, docetaxel and ifosfamide in advanced or recurrent non-small cell lung cancer. / Kunitoh, Hideo; Akiyama, Yoshiko; Kusaba, Hitoshi; Yamamoto, Noboru; Sekine, Ikuo; Ohe, Yuichiro; Kubota, Kaoru; Tamura, Tomohide; Shinkai, Tetsu; Kodama, Tetsuro; Goto, Koichi; Niho, Seiji; Nishiwaki, Yutaka; Saijo, Nagahiro.

In: Lung Cancer, Vol. 33, No. 2-3, 15.08.2001, p. 259-265.

Research output: Contribution to journalArticle

Kunitoh, H, Akiyama, Y, Kusaba, H, Yamamoto, N, Sekine, I, Ohe, Y, Kubota, K, Tamura, T, Shinkai, T, Kodama, T, Goto, K, Niho, S, Nishiwaki, Y & Saijo, N 2001, 'A phase I/II trial of cisplatin, docetaxel and ifosfamide in advanced or recurrent non-small cell lung cancer', Lung Cancer, vol. 33, no. 2-3, pp. 259-265. https://doi.org/10.1016/S0169-5002(01)00189-1
Kunitoh, Hideo ; Akiyama, Yoshiko ; Kusaba, Hitoshi ; Yamamoto, Noboru ; Sekine, Ikuo ; Ohe, Yuichiro ; Kubota, Kaoru ; Tamura, Tomohide ; Shinkai, Tetsu ; Kodama, Tetsuro ; Goto, Koichi ; Niho, Seiji ; Nishiwaki, Yutaka ; Saijo, Nagahiro. / A phase I/II trial of cisplatin, docetaxel and ifosfamide in advanced or recurrent non-small cell lung cancer. In: Lung Cancer. 2001 ; Vol. 33, No. 2-3. pp. 259-265.
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AU - Akiyama, Yoshiko

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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

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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.

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