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- Title
A Phase I study of cabazitaxel in patients with advanced gastric cancer who have failed prior chemotherapy (GASTANA).
- Authors
Kang, Yoon-Koo; Ryoo, Baek-Yeol; Yoon, Shinkyo; Shen, Lin; Lee, Jooyun; Wei, Chenlu; Zhou, Yu; Ryu, Min-Hee
- Abstract
Purpose: This Phase I dose-escalation study (GASTANA) evaluated the safety, tolerability, pharmacokinetics and preliminary antitumor activity of cabazitaxel in Asian patients with advanced gastric adenocarcinoma failing two prior chemotherapy regimens. Methods: Cabazitaxel safety/tolerability was determined using a standard 3 + 3 dose-escalation design based on dose-limiting toxicities (DLTs) in Cycle 1. Three dose levels (DL) were planned: 20, 25 and 15 mg/m (DL 1, DL 2 and DL −1). Results: Fifteen patients were evaluable for DLTs. At DL 1, no DLTs occurred in three patients. At DL 2, four patients were enrolled (one patient discontinued), with only one DLT observed [Grade 4 febrile neutropenia (FN)]; however, all four patients experienced FN, hence three more patients were enrolled at DL 1 who experienced two DLTs (Grade 4 neutropenia >7 days). In response, DL −1 was opened, with no DLTs observed in six patients. In the total population ( n = 16), frequent Grade 3/4 toxicities included neutropenia (63 %) and FN (38 %), best overall responses included one partial response (6.3 %; DL −1) and eight stable disease (50 %), and median progression-free survival was 83 days. Conclusions: No unexpected safety findings were observed. Significant toxicities included neutropenia and FN, potentially due to patients being heavily pretreated and the accumulated toxicity of prior taxane therapy.
- Subjects
CABAZITAXEL; STOMACH cancer patients; CANCER chemotherapy; DRUG dosage; MEDICATION safety; DRUG tolerance; CLINICAL trials; THERAPEUTICS
- Publication
Cancer Chemotherapy & Pharmacology, 2015, Vol 75, Issue 2, p309
- ISSN
0344-5704
- Publication type
Article
- DOI
10.1007/s00280-014-2638-y