Advanced Pancreatic Cancer. MedDRA version: 11.1 Level: LLT Classification code 10033604 Term:
Conditions
Sponsors
sanofi-aventis recherche & developpement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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 5 years prior to randomization, will be eligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;Secondary Objective: *To compare on the two treatment arms:· -Progression Free Survival (PFS), -Overall Response Rate (ORR), -Clinical Benefit assessed by Time to symptoms worsening (TTSW) and improvement in tumor related symptoms, *To assess the overall safety of the two arms, *To assess the pharmacokinetics of larotaxel in this patient population (sample size of 50 larotaxel-treated patients for sparse sampling). | — |
Countries
Belgium, Czech Republic, Finland, Germany, Hungary, Italy, Spain, United Kingdom
Outcome results
None listed