A phase II study

Autor: J.P. Armand, P. Baille, M. de Forni, Ph. Rougier, J. Bonneterre, Michel Ducreux, P. Clouet, M. Dembak, A. Lebecq, C. Blanc, Antoine Adenis, F. Lefresne-Soulas
Rok vydání: 2000
Předmět:
Zdroj: European Journal of Cancer. 36:1016-1025
ISSN: 0959-8049
DOI: 10.1016/s0959-8049(00)00072-1
Popis: The aim of this study was to evaluate the efficacy of docetaxel as first-line chemotherapy in patients with unresectable metastatic or locally advanced pancreatic adenocarcinoma and to further characterise the safety and pharmacokinetic profiles of docetaxel. 43 patients were enrolled into this phase II study. Treatment consisted of a 1-h infusion of docetaxel 100 mg/m 2 every 3 weeks without premedication with corticosteroids until progression or unacceptable toxicity occurred. Dose modifications were planned for adverse events. Patients were observed for 1 month after the last docetaxel infusion, to document any late adverse events, with a follow-up every 3 months until death. Response rate and duration were the major efficacy endpoints. Response status was reviewed by an external independent panel. Pharmacokinetic analysis was performed during the first treatment cycle. 40 patients were evaluable for response, and all were evaluable for safety. After independent review, partial response was recorded in 6 patients (overall response rate, 15%; 95% confidence limit (CI), 7.7–29.8%) and stable disease was recorded in 15 patients (38%). The median duration of response was 5.1 months (range: 3.1–7.2). The median pain control time was 4.5 months (range: 0–8) and the median time to performance status worsening was 2.3 months (range: 0–4.5). Most patients 40 (93.0%) received a relative dose intensity of more than 70% of the planned dose. The incidence and severity of adverse events reflected the known safety profile for docetaxel. Docetaxel clearance was reduced in patients with elevated concentrations of hepatic enzymes or bilirubin. Docetaxel is an active agent for unresectable metastatic or locally advanced pancreatic adenocarcinoma.
Databáze: OpenAIRE
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