Study of Individualized Selection of Chemotherapy in Patients With Advanced Pancreatic Carcinoma According to Therapeutic Targets
Condition: Advanced Pancreatic Carcinoma
MeSH terms: Carcinoma; Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the proportion of patients alive after 12 months of
      the beginning of the trial in patients with advanced pancreatic carcinoma individually
      selected and grouped according to the expression in tumor tissue for therapeutic targets.
    

Detailed description: 
      Phase II, open two branches, in which conventional treatment is administered to patients
      diagnosed with metastatic pancreatic carcinoma. Patients will be randomized (1:1) to a
      treatment arm or control arm of experimental treatment guided by the therapeutic targets.
      Patients in the control treatment arm will be treated with any of the schemes used in the
      study according to the discretion of the physician responsible. Patients will be analyzed as
      "intention to treat." In the experimental treatment arm (therapeutic targets) and within 15
      days will determine the markers of therapeutic targets detailed in the protocol, either from
      pre-existing tumor sample or a fresh sample obtained by biopsy. Based on the results of this
      analysis, we prescribe a chemotherapy treatment determined for possible treatments currently
      used in pancreatic carcinoma, gemcitabine, gemcitabine and capecitabine, gemcitabine and
      erlotinib, FOLFIRINOX, FOLFOX, FOLFIRI.

      Treatment duration is indefinite .
    

Intervention name(s): gemcitabine, or gemcitabine and capecitabine, or gemcitabine and erlotinib, or FOLFIRINOX, or FOLFOX, or FOLFIRI.; Gemcitabine, Gemcitabine-Capecitabine, Gemcitabine-Erlotinib, FOLFOXIRI, FOLFOX, FOLFIRI
Intervention type(s): Drug; Drug
Intervention description(s): Gemcitabine 1000 mg/m2 weekly for 7 weeks, then weekly regimen of 3 weeks every 4 weeks.
Gemcitabine - Capecitabine (GEM-CAP):Gemcitabine 1000 mg/m2 weekly for 3 weeks, Capecitabine 830 mg/m2 orally every 12 hours daily for 3 weeks; every 4 weeks.
Gemcitabine-Erlotinib: Gemcitabine 1000 mg/m2 weekly for 7 weeks, then weekly regimen of 3 weeks every 4 weeks, Erlotinib 100 mg orally daily
FOLFOXIRI: Oxaliplatin 85 mg/m2,irinotecan 180 mg/m2, folinic acid 400 mg/m2, 5'Fluouracilo 400 mg / m2, 5 'fluorouracil 2400 mg/m2 continuous intravenous infusion of 46 hours. Repeated every 14 days.
FOLFOX: Oxaliplatin 85 mg/m2, folinic acid 400 mg/m2, 400 mg/m2 5'Fluouracilo, 2400 mg/m2 5'Fluouracilo continuous intravenous infusion of 46 hours. Repeated every 14 days.
FOLFIRI: Irinotecan 180 mg/m2, folinic acid 400 mg/m2, 400 mg/m2 5'Fluouracilo intravenous bolus, 5'Fluouracilo 2400 mg / m2 continuous intravenous infusion for 46 hours. Repeated every 14 days.; Gemcitabine 1000 mg/m2 weekly for 7 weeks, then weekly regimen of 3 weeks every 4 weeks.
Gemcitabine - Capecitabine (GEM-CAP):Gemcitabine 1000 mg/m2 weekly for 3 weeks, Capecitabine 830 mg/m2 orally every 12 hours daily for 3 weeks; every 4 weeks.
Gemcitabine-Erlotinib: Gemcitabine 1000 mg/m2 weekly for 7 weeks, then weekly regimen of 3 weeks every 4 weeks, Erlotinib 100 mg orally daily
FOLFOXIRI: Oxaliplatin 85 mg/m2,irinotecan 180 mg/m2, folinic acid 400 mg/m2, 5'Fluouracilo 400 mg / m2, 5 'fluorouracil 2400 mg/m2 continuous intravenous infusion of 46 hours. Repeated every 14 days.
FOLFOX: Oxaliplatin 85 mg/m2, folinic acid 400 mg/m2, 400 mg/m2 5'Fluouracilo, 2400 mg/m2 5'Fluouracilo continuous intravenous infusion of 46 hours. Repeated every 14 days.
FOLFIRI: Irinotecan 180 mg/m2, folinic acid 400 mg/m2, 400 mg/m2 5'Fluouracilo intravenous bolus, 5'Fluouracilo 2400 mg / m2 continuous intravenous infusion for 46 hours. Repeated every 14 days.
Intervention MeSH terms: Leucovorin; Gemcitabine; Capecitabine; Fluorouracil; Erlotinib Hydrochloride; Oxaliplatin; Folfirinox
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Therapeutic targets in Pancreas