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

Not Applicable

Conditions: -C259 Pancreas, unspecified
Pancreas, unspecified
C259

Registration Number: PER-151-08

Lead Sponsor: sanofi-aventis Recherche & Development,

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:OS is defined as the number of months from the date of random assignment to the date of death. If the patient does not die during the study, OS data will be entered on the last date on which it is known that the subject is alive or the deadline, whichever is earlier.<br>Measure:General Survival (OS)<br>Timepoints:During the study<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:PFS is defined as the number of months from the date of random assignment to the date of the first observation of progression or the date of death (for any reason). If death and progression do not occur, the PFS data will be censored at the earliest date, be it the date of the last tumor evaluation without evidence of progression and the study deadline.<br>Measure:Progression Free Survival (PFS)<br>Timepoints:During the study<br>;<br>Outcome name:RR is defined as the proportion of patients with confirmed complete response (CR) or confirmed partial response (PR), defined by RECIST (Appendix C), in relation to the total number of patients in the ITT population with measurable disease upon admission at study and population of evaluable patients for tumor response, respectively. Tumor evaluations carried out until the start of another antitumor treatment will be taken into account.<br>Measure:Objective Response Index (RR)<br>Timepoints:During the study<br>

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