PER-151-08已完成未知
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 & Development,0 个研究点目标入组 0 人开始时间: 2009年1月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 80（—）
入选标准
- •Evidence of epithelial cancer (adenocarcinoma) of the cytologically or histologically confirmed exocrine pancreas.
- •Advanced disease, defined as non-operable disease with curative, locally recurrent or metastatic intention. Patients with non-measurable disease are eligible (according to the RECIST criteria).
- •The patient must have been previously treated with a systemic regimen based on gemcitabine administered as adjuvant chemotherapy (the disease-free interval must be less than 6 months) or as a treatment for advanced disease. Patients treated with prior chemo-radiation for the primary pancreatic tumor are also eligible, in which the chemotherapy agent has been used as a radio sensitizing agent.
排除标准
- •Disease located only in the radiation fields without progression of the disease confirmed by radiological means in the radiation fields after completing the previous radiation therapy.
- •More than one previous chemotherapy regimen for advanced pancreatic disease
- •Prior locoregional radiation therapy for pancreatic cancer
- •Less than 4 weeks from previous chemotherapy (except for the weekly regimen for which 3 weeks are allowed) or prior radiotherapy, less than 3 weeks from surgery and less than 10 days from the last previous administration of erlotinib at the time of random assignment.
- •Adverse events (except alopecia and those listed in the specific exclusion criteria) for any previous treatment with grade> 1 according to the Common Terminology Criteria for Adverse Events (CCTAE) of the National Cancer Institute (NCI), version 3.0 at the time of random assignment.
- •Patients under 18 years of age.
- •Performance status according to ECOG (Eastern Cooperative Cancer Group) of 2, 3 or 4
- •Symptomatic brain metastasis or leptomeningeal disease (CT or MRJ scan of the brain is only required in case of clinical suspicion of central nervous system involvement).
- •History of another neoplasm. Patients with a previous history of non-melanoma skin cancer, cervical carcinoma in situ or cancer cured by surgery, small field radiation or chemotherapy> 5 years before randomisation are eligible
- •History of inflammatory bowel disease, significant intestinal obstruction.
- •History of grade 3 hypersensitivity to taxanes, Polysorbate-80 or compounds with similar chemical structures. History of hypersensitivity to fluoropyrimidines.
- •Known deficiency of dihydropyrimidine dehydrogenase. (For the researcher who chose capecitabine as a control arm, patients with lack of physical integrity of the upper digestive tract, syndrome of malabsorption or inability to take oral medications) will be excluded.
- •Known infection with human immunodeficiency virus (HIV) that requires treatment or disease related to acquired immunodeficiency syndrome (AIDS).
- •Any other active disease, such as uncontrolled active infections, uncontrolled heart disease or hypertension, uncontrolled diabetes that prevents the safe administration of the study treatment at the time of randomization. Any of the following phenomena in the 6 months prior to randomization: myocardial infarction; severe / unstable angina; revascularization procedure with coronary or peripheral arterial graft; symptomatic or uncontrolled cardiovascular disease, or arrhythmias of clinical importance (grade 3-4).
- •Concurrent treatment with potent cytochrome P450 3A4 inhibitors (see Appendix G) or patients planning to receive these treatments. For patients who were receiving these drugs, an elimination period of one week is required before randomization.
- •Concurrent participation in another clinical study or other antineoplastic therapy.
- •Pregnant or breastfeeding women. Positive serum or urinary pregnancy test before randomisation.
- •Patient with reproductive potential (M / F) who does not implement an accepted and effective contraceptive method (the definition of effective contraceptive method depends on the investigator´s criteria). For patients included in the United Kingdom, the following contraceptive methods are acceptable
- •Patient who is not willing or unable to comply with scheduled visits, treatment plans, laboratory tests or
研究者
相似试验
进行中（未招募）
不适用
A Randomized, Open Label Multi-Center Study of Single Agent Larotaxel XRP9881 at 90 mg/m2 every 3 weeks Compared to Continuous Administration of 5-FU For The Treatment of Patients With Advanced Pancreatic Cancer Previously Treated With A Gemcitabine-Containing Regimen - PAPRIKAEUCTR2006-003086-14-ITsanofi-aventis recherche developpement400
进行中（未招募）
不适用
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 - PAPRIKAEUCTR2006-003086-14-CZsanofi-aventis recherche & developpement434
进行中（未招募）
不适用
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 - PAPRIKAAdvanced Pancreatic Cancer.MedDRA version: 11.1Level: LLTClassification code 10033604Term: <Manually entered code. Term in E.1.1>MedDRA version: 9.1Level: LLTClassification code 10033604Term: Pancreatic cancerEUCTR2006-003086-14-HUsanofi-aventis recherche & developpement434
进行中（未招募）
1 期
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” - PAPRIKAAdvanced Pancreatic Cancer.--------------------------------Cáncer Pancreático avanzado.MedDRA version: 8.1Level: LLTClassification code 10033609Term: Pancreatic carcinomaEUCTR2006-003086-14-ESsanofi-aventis recherche & developpement400
进行中（未招募）
不适用
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 - PAPRIKAAdvanced Pancreatic CancerMedDRA version: 11.1Level: LLTClassification code 10033604Term: <Manually entered code. Term in E.1.1>EUCTR2006-003086-14-BEsanofi-aventis recherche & developpement434