A Randomized, Open Label Multi-Center Study of Single Agent Larotaxel (XRP9881) Compared to Continuous Administration of 5-FU For The Treatment of Patients With Advanced Pancreatic Cancer Previously Treated With A Gemcitabine-Containing Regimen.------------------------------------------------------------------------------------------------Estudio aleatorizado, abierto y multicéntrico de monoterapia con larotaxel (XRP9881), comparado con la administración continua de 5-fluorouracilo para el tratamiento del cáncer de páncreas avanzado en pacientes tratados previamente con una pauta de gemcitabina” - PAPRIKA

sanofi-aventis recherche & developpement0 个研究点目标入组 400 人开始时间: 2010年3月10日最近更新: 2021年10月8日

适应症

试验速览

暂无简介。

•*Cytologically or histologically confirmed evidence of epithelial cancer (adenocarcinoma) of the exocrine pancreas.
•*Advanced disease defined as non operable in a curative intent, locally recurrent or metastatic disease. Patients with non-measurable disease (as per RECIST criteria) are eligible.
•*Patient must be previously treated with a systemic gemcitabine based regimen given as adjuvant chemotherapy (disease free interval must be less than 6 months) or as therapy for advanced disease. Patients treated in addition with prior chemo-radiation to the primary pancreatic tumor, in which the chemotherapeutic agent was used as a radio-sensitizing agent, are eligible.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•*More than one previous chemotherapy regimen for advanced pancreatic disease.
•*Prior locoregional radiotherapy for pancreatic disease.
•*ECOG performance status (PS) of 2-3-4.
•*History of hypersensitivity grade 3 to taxanes, Polysorbate-80, or to compounds with similar chemical structures.History of hypersensitivity to fluoropyrimidines.
•*Known dihydropyrimidine dehydrogenase deficiency.
•*Concurrent treatment with strong inhibitors of cytochrome P450 3A4 or patients planning to receive these treatments. For patients who were receiving treatment with such agents, a one-week washout period is required prior to randomization.

发起方

sanofi-aventis recherche & developpement