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 - PAPRIKA
- Conditions
- Advanced Pancreatic CancerMedDRA version: 9.1Level: LLTClassification code 10033609Term: Pancreatic carcinoma
- Registration Number
- EUCTR2006-003086-14-IT
- Lead Sponsor
- sanofi-aventis recherche developpement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
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. ECOG performance status PS of 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method