Phase II Study of Chemotherapy Selection Based on Therapeutic Targets for the Treatment of Advanced Pancreatic Cancer
Study Phase: Phase 2 Trial
- Primary end-point. Proportion of patients alive after 12 months in patients with
advanced pancreatic carcinoma individually selected and grouped according to the
expression in tumor tissue for therapeutic targets.
- Secondary end-points. 1. Assessing the feasibility of the method of
patient-treatment-selection based on tumor tissue expression of therapeutic targets. 2.
Overal survival comparison between Gemcitabine single agent treatment and the rest of
chemotherapy schedules. 3. Determination of progression-free survival for each
treatment group. 4. Determination of toxicity in all the patients.
Study population and Number of subject: A total of 60 pancreatic cancer patients with
advanced pancreas cancer with no previous systemic treatment are expected to be enrolled.
Study design and schedule. Patients will be randomized (1:1) to a control arm or an
experimental treatment arm guided by therapeutic targets. In the control arm, patients are
treated with conventional chemotherapy regimens at the discretion of the investigator. In
the experimental arm, patients are treated as determined in tumor tissue available for
biomarker TS, TP, ERCC-1, Topo-1, K-Ras mutation and EGFR FISH, choosing FOLFIRINOX schemas,
FOLFOX, FOLFIRI, Gemcitabine-Capecitabine Gemcitabine-Erlotinib, Gemcitabine single agent.
All patients will be analyzed by intention to treat
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Manuel Hidalgo, MD
Spain: Agencia Española de Medicamentos y Productos Sanitarios