MedTrace Logo

Study of Individualized Selection of Chemotherapy in Patients With Advanced Pancreatic Carcinoma According to Therapeutic Targets

NCT01454180 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2015-10-09

No results posted yet for this study

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.

Conditions

  • Advanced Pancreatic Carcinoma

Interventions

DRUG

gemcitabine, or gemcitabine and capecitabine, or gemcitabine and erlotinib, or FOLFIRINOX, or FOLFOX, or FOLFIRI.

* 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.

DRUG

Gemcitabine, Gemcitabine-Capecitabine, Gemcitabine-Erlotinib, FOLFOXIRI, FOLFOX, FOLFIRI

* 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.

Sponsors & Collaborators

  • Hospital Universitario de Fuenlabrada

    collaborator OTHER

  • Apices Soluciones S.L.

    collaborator INDUSTRY

  • Grupo Hospital de Madrid

    collaborator OTHER

  • Centro Nacional de Investigaciones Oncologicas CARLOS III

    lead OTHER

Principal Investigators

  • Manuel Hidalgo, M.D.,PhD · CNIO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2011-10-31
Completion
2014-12-31

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01454180 on ClinicalTrials.gov