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

Phase 1

• Conditions: Advanced Pancreatic Cancer.--------------------------------Cáncer Pancreático avanzado.; MedDRA version: 8.1Level: LLTClassification code 10033609Term: Pancreatic carcinoma

• Registration Number: EUCTR2006-003086-14-ES
• Lead Sponsor: sanofi-aventis recherche & developpement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2009-11-21
• Study Start: 2010-03-10
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

*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

Exclusion Criteria

*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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether single agent larotaxel increases overall survival when compared to continuous administration of 5-Fluorouracil (5-FU) in patients with advanced pancreatic cancer previously treated with a gemcitabine-based therapy;Primary end point(s): Overall survival will be assessed from the date of randomization to death.;Secondary Objective: *To compare on the two treatment arms:·<br>-Progression Free Survival (PFS),<br>-Overall Response Rate (ORR), <br>-Clinical Benefit assessed by Time to symptoms worsening (TTSW) and improvement in tumor related symptoms,<br><br>*To assess the overall safety of the two arms,<br><br>*To assess the pharmacokinetics of larotaxel in this patient population (sample size of 50 larotaxel-treated patients for sparse sampling).