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 - PAPRIKA

sanofi-aventis recherche & developpement0 个研究点目标入组 434 人开始时间: 2008年11月19日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1. Cytologically or histologically confirmed evidence of epithelial cancer (adenocarcinoma) of the exocrine pancreas.
•2. Advanced disease defined as non operable in a curative intent, locally advanced or metastatic disease. Patients with nonmeasurable disease (as per RECIST criteria) are eligible.
•3. 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.
•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

•Disease localized only to the radiation fields without radiologically confirmed progression of the disease within the radiation fields after completion of prior radiotherapy.
•Prior therapy:
•- More than one previous chemotherapy regimen for advanced pancreatic disease.
•- Prior locoregional radiotherapy for pancreatic cancer.
•- Less than 4 weeks elapsed from prior chemotherapy (except for weekly regimen for which 3 weeks are allowed) or radiotherapy, less than 3 weeks from surgery and less than 10 days from last prior administration of erlotinib, to the time of randomization.
•General conditions:
•- Age < 18 years.
•- ECOG performance status (PS) of 2-3-4.
•- Patient with organ functions as follows: ANC < 2,000/mm3, platelets < 100,000/mm3, hemoglobin < 10 g/dL, total bilirubin > ULN, SGOT/SGPT > 1.5 x ULN if AP = 5 and > 2.5 x ULN or SGOT/SGPT > 2.5 x ULN if AP = 2.5 x UNL, AP > 5 x ULN, Serum creatinine > 1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, a creatinine clearance calculated according to Cockcroft-Gault formula < 60 mL/min will exclude the patient.
•Prior or current history:
•History of another neoplasm. Patients with prior history of either non-melanoma skin cancers, carcinoma in situ of the cervix, or cancer cured by surgery, small field radiation or chemotherapy > 5 years prior to randomization, will be eligible.

发起方

sanofi-aventis recherche & developpement