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Phase I study on docetaxel and ifosfamide in patients with advanced solid tumours.

Docetaxel and ifosfamide have shown significant activity against a variety of solid tumours. This prompted a phase I trial on the combination of these drugs. This phase I study was performed to assess the feasibility of the combination, to determine the maximum tolerated dose (MTD) and the side effe...

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Autores principales: Pronk, L. C., Schrijvers, D., Schellens, J. H., de Bruijn, E. A., Planting, A. S., Locci-Tonelli, D., Groult, V., Verweij, J., van Oosterom, A. T.
Formato: Texto
Lenguaje:English
Publicado: Nature Publishing Group 1998
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2151260/
https://www.ncbi.nlm.nih.gov/pubmed/9459161
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author Pronk, L. C.
Schrijvers, D.
Schellens, J. H.
de Bruijn, E. A.
Planting, A. S.
Locci-Tonelli, D.
Groult, V.
Verweij, J.
van Oosterom, A. T.
author_facet Pronk, L. C.
Schrijvers, D.
Schellens, J. H.
de Bruijn, E. A.
Planting, A. S.
Locci-Tonelli, D.
Groult, V.
Verweij, J.
van Oosterom, A. T.
author_sort Pronk, L. C.
collection PubMed
description Docetaxel and ifosfamide have shown significant activity against a variety of solid tumours. This prompted a phase I trial on the combination of these drugs. This phase I study was performed to assess the feasibility of the combination, to determine the maximum tolerated dose (MTD) and the side effects, and to propose a safe schedule for further phase II studies. A total of 34 patients with a histologically confirmed solid tumour, who were not pretreated with taxanes or ifosfamide and who had received no more than one line of chemotherapy for advanced disease were entered into the study. Treatment consisted of docetaxel given as a 1-h infusion followed by ifosfamide as a 24-h infusion (schedule A), or ifosfamide followed by docetaxel (schedule B) every 3 weeks. Docetaxel doses ranged from 60 to 85 mg m(-2) and ifosfamide doses from 2.5 to 5.0 g m(-2). Granulocytopenia grade 3 and 4 were common (89%), short lasting and ifosfamide dose dependent. Febrile neutropenia and sepsis occurred in 17% and 2% of courses respectively. Non-haematological toxicities were mild to moderate and included alopecia, nausea, vomiting, mucositis, diarrhoea, sensory neuropathy, skin and nail toxicity and oedema. There did not appear to be any pharmacokinetic interaction between docetaxel and ifosfamide. One complete response (CR) (soft tissue sarcoma) and two partial responses (PRs) were documented. A dose of 75 mg m(-2) of docetaxel combined with 5.0 g m(-2) ifosfamide appeared to be manageable. Schedule A was advocated for further treatment.
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spelling pubmed-21512602009-09-10 Phase I study on docetaxel and ifosfamide in patients with advanced solid tumours. Pronk, L. C. Schrijvers, D. Schellens, J. H. de Bruijn, E. A. Planting, A. S. Locci-Tonelli, D. Groult, V. Verweij, J. van Oosterom, A. T. Br J Cancer Research Article Docetaxel and ifosfamide have shown significant activity against a variety of solid tumours. This prompted a phase I trial on the combination of these drugs. This phase I study was performed to assess the feasibility of the combination, to determine the maximum tolerated dose (MTD) and the side effects, and to propose a safe schedule for further phase II studies. A total of 34 patients with a histologically confirmed solid tumour, who were not pretreated with taxanes or ifosfamide and who had received no more than one line of chemotherapy for advanced disease were entered into the study. Treatment consisted of docetaxel given as a 1-h infusion followed by ifosfamide as a 24-h infusion (schedule A), or ifosfamide followed by docetaxel (schedule B) every 3 weeks. Docetaxel doses ranged from 60 to 85 mg m(-2) and ifosfamide doses from 2.5 to 5.0 g m(-2). Granulocytopenia grade 3 and 4 were common (89%), short lasting and ifosfamide dose dependent. Febrile neutropenia and sepsis occurred in 17% and 2% of courses respectively. Non-haematological toxicities were mild to moderate and included alopecia, nausea, vomiting, mucositis, diarrhoea, sensory neuropathy, skin and nail toxicity and oedema. There did not appear to be any pharmacokinetic interaction between docetaxel and ifosfamide. One complete response (CR) (soft tissue sarcoma) and two partial responses (PRs) were documented. A dose of 75 mg m(-2) of docetaxel combined with 5.0 g m(-2) ifosfamide appeared to be manageable. Schedule A was advocated for further treatment. Nature Publishing Group 1998 /pmc/articles/PMC2151260/ /pubmed/9459161 Text en https://creativecommons.org/licenses/by/4.0/This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit https://creativecommons.org/licenses/by/4.0/.
spellingShingle Research Article
Pronk, L. C.
Schrijvers, D.
Schellens, J. H.
de Bruijn, E. A.
Planting, A. S.
Locci-Tonelli, D.
Groult, V.
Verweij, J.
van Oosterom, A. T.
Phase I study on docetaxel and ifosfamide in patients with advanced solid tumours.
title Phase I study on docetaxel and ifosfamide in patients with advanced solid tumours.
title_full Phase I study on docetaxel and ifosfamide in patients with advanced solid tumours.
title_fullStr Phase I study on docetaxel and ifosfamide in patients with advanced solid tumours.
title_full_unstemmed Phase I study on docetaxel and ifosfamide in patients with advanced solid tumours.
title_short Phase I study on docetaxel and ifosfamide in patients with advanced solid tumours.
title_sort phase i study on docetaxel and ifosfamide in patients with advanced solid tumours.
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2151260/
https://www.ncbi.nlm.nih.gov/pubmed/9459161
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