Chemotherapy Selection Based on Therapeutic Targets for Advanced Pancreatic Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Grupo Hospital de Madrid.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Sofia Perea, Director Clinical Trials Unit., Grupo Hospital de Madrid
ClinicalTrials.gov Identifier:
NCT01394120
First received: July 5, 2011
Last updated: March 24, 2012
Last verified: March 2012
  Purpose

In recent years, treatment of advanced pancreatic cancer is changing. Currently, there are several active schedules of chemotherapy that can be used, such as gemcitabine as monotherapy or in combination with capecitabine or erlotinib, and FOLFIRINOX. Moreover, the development of biomarker (therapeutic targets) that can predicte response to treatment is a new important tool to be used in clinical practice to select the best scheme for each patient. Preliminary studies showed that therapeutic target determination, using tumor tissue collected from patients, could determine the presence of groups of "chemotherapy responders". Such is the case of EGFR amplification and/or K-Ras gene status and correlation with response to erlotinib. Moreover, Thymidilate Synthase, Thimidine Phosphorylase, ERCC-1 and Topoisomerase I expression by immunohistochemistry in GI tumor samples has been related to resistance or response to 5FU-capecitabine, oxaliplatin and irinotecan respectively. Based on this data the investigators designed a phase II clinical trial to evaluate the efficacy of selected treatment for pancreatic cancer patients based on the determination of therapeutic targets. The therapeutic target-driven treatment efficacy will be compared to the prospective treatment of a control group of patients treated at the discretion of the physician-researcher


Condition Intervention Phase
Carcinoma, Pancreatic Ductal
Drug: Targeted Therapy Tailored Treatment
Drug: Standard Chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Chemotherapy Selection Based on Therapeutic Targets for the Treatment of Advanced Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Grupo Hospital de Madrid:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tarteted Therapy Drug: Targeted Therapy Tailored Treatment

Targeted therapy tailored treatment, based on molecular determination in pancreas cancer specimen

  • Tim Synthase (TS) (neg), ERCC-1 (neg), Topoisomerase I (Topo I) (pos) : FOLFIRINOX
  • TS (neg), ERCC-1 (neg), Topo I (neg): FOLFOX
  • TS (neg), ERCC-1 (pos), Topo I (pos): FOLFIRI
  • TS (neg), ERCC-1 (pos), Topo I (neg): Capecitabine/Gemcitabine
  • TS (pos), EGFR Not Amplificate, K-Ras Mutation (pos) : Gemcitabine single agent
  • TS (pos), EGFR Ampl or K-Ras mut (neg): Gemcitabine plus Erlotinib
Other Name: Individualized treatment selection based on predictors of response biomarkers
Active Comparator: Standard Chemotherapy Drug: Standard Chemotherapy
Patients treated based on investigator´s criteria: : FOLFIRINOX, FOLFOX, FOLFIRI, Capecitabine-Gemcitabine, Erlotinib-Gemcitabine or Gemcitabine single agent
Other Name: Treatment at the investigator's discretion

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 targets
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394120

Locations
Spain
Centro Integral Oncologico Clara Campal Recruiting
Madrid, Spain, 28050
Contact: Manuel Hidalgo, MD, PhD       mhidalgo@cnio.es   
Sub-Investigator: Jesus Rodriguez-Pascual         
Sub-Investigator: Antonio Cubillo         
Sub-Investigator: Pia Morelli         
Sub-Investigator: Elena Garcia         
Sub-Investigator: Barbara Angulo         
Sub-Investigator: Ulpiano Lopez de la Guardia         
Sub-Investigator: Emilio de Vicente         
Sub-Investigator: Eduardo Garcia-Rico         
Sub-Investigator: Ignacio Juez         
Sub-Investigator: Ana Ruiz         
Sponsors and Collaborators
Sofia Perea, Director Clinical Trials Unit.
Investigators
Principal Investigator: Manuel Hidalgo, MD
  More Information

No publications provided

Responsible Party: Sofia Perea, Director Clinical Trials Unit., Director Clinical Trial Unit, Grupo Hospital de Madrid
ClinicalTrials.gov Identifier: NCT01394120     History of Changes
Other Study ID Numbers: TARGTHPANC 001, 2011-001017-13
Study First Received: July 5, 2011
Last Updated: March 24, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Grupo Hospital de Madrid:
Pancreas cancer
Targeted Therapy

Additional relevant MeSH terms:
Pancreatic Neoplasms
Carcinoma, Pancreatic Ductal
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Carcinoma, Ductal
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on October 01, 2014