Phase I-II study of biweekly paclitaxel administration with fixed-dose-rate cisplatin in advanced gastric cancer View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2006-02

AUTHORS

Kensei Yamaguchi, Tomotaka Shimamura, Yoshito Komatsu, Akinori Takagane, Takashi Yoshioka, Soh Saitoh, Masaki Munakata, Yu Sakata, Tsukasa Sato, Tatsuhiro Arai, Hiroshi Saitoh, East Japan Gastric Cancer Study Group

ABSTRACT

BackgroundBoth paclitaxel (TXL) and cisplatin (CDDP) show efficacy against gastric cancer. The aim of this phase I-II study was to determine the maximum tolerated dose (MTD) and to evaluate the toxicity and efficacy of combination chemotherapy with these two agents.MethodsNineteen patients entered the phase I part of the study, and 21 patients entered the phase II part. TXL infusions were administered on days 1 and 15, with a fixed 3mg/m2 dose of CDDP.ResultsIn the phase I part of the study, we determined dose level 5, which represented a TXL dose of 18mg/m2, with CDDP 3mg/m2, to be the MTD. The recommended dose (RD) was level 4, with a TXL dose of 16mg/m2 with CDDP, 3mg/m2. In the phase II part of the study, the response rate was 25.0%; five patients had a partial response, seven had stable disease, 6 had progressive disease, and 2 were not evaluable. Grade 3 or 4 neutropenia was the most common adverse event and occurred in 65% of the patients. During treatment, 25% of the patients received granulocyte colony-stimulating factor, but febrile neutropenia was not shown in any of the patients. Major nonhematological toxicities were nausea/vomiting, anorexia, fatigue, alopecia, and sensory neuropathy. Adverse reactions of grade 3 or 4 were shown by two patients, one with anorexia (5%) and the other with sensory neuropathy (5%).ConclusionThe RD was determined to be TXL 14mg/m2, with CDDP 3mg/m2. More... »

PAGES

36-43

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s10120-005-0355-2

DOI

http://dx.doi.org/10.1007/s10120-005-0355-2

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1034399982

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/16557435


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