Know Cancer

forgot password

Phase II Study of Chemotherapy Selection Based on Therapeutic Targets for the Treatment of Advanced Pancreatic Cancer

Phase 2
18 Years
Open (Enrolling)
Carcinoma, Pancreatic Ductal

Thank you

Trial Information

Phase II Study of Chemotherapy Selection Based on Therapeutic Targets for the Treatment of Advanced Pancreatic Cancer

Study Phase: Phase 2 Trial

Study Objetives:

- 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

Inclusion Criteria:

- Histologic diagnosis of pancreas adenocarcinoma

- Clinical stage IV

- Feasible patient for chemotherapy

- Availability of tumor tissue or possibility of a tumor biopsy to define therapeutic

- Informed written consent

Exclusion Criteria:

- Previous systemic treatment for advanced pancreas adenocarcinoma

- Contraindication to the administration of any of the drugs used in the study:
capecitabine, 5Fluouracil, irinotecan, oxaliplatin, gemcitabine or erlotinib

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Manuel Hidalgo, MD

Investigator Role:

Principal Investigator


Spain: Agencia EspaƱola de Medicamentos y Productos Sanitarios

Study ID:




Start Date:

August 2011

Completion Date:

December 2013

Related Keywords:

  • Carcinoma, Pancreatic Ductal
  • Pancreas cancer
  • Targeted Therapy
  • Carcinoma
  • Pancreatic Neoplasms
  • Carcinoma, Pancreatic Ductal