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Chemotherapy Selection Based on Therapeutic Targets for Advanced Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01394120
Recruitment Status : Unknown
Verified March 2012 by Sofia Perea, Director Clinical Trials Unit., Grupo Hospital de Madrid.
Recruitment status was:  Recruiting
First Posted : July 14, 2011
Last Update Posted : March 27, 2012
Information provided by (Responsible Party):
Sofia Perea, Director Clinical Trials Unit., Grupo Hospital de Madrid

Brief Summary:
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 or disease Intervention/treatment Phase
Carcinoma, Pancreatic Ductal Drug: Targeted Therapy Tailored Treatment Drug: Standard Chemotherapy Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Chemotherapy Selection Based on Therapeutic Targets for the Treatment of Advanced Pancreatic Cancer
Study Start Date : August 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01394120

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Centro Integral Oncologico Clara Campal Recruiting
Madrid, Spain, 28050
Contact: Manuel Hidalgo, MD, PhD   
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.
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Principal Investigator: Manuel Hidalgo, MD

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Responsible Party: Sofia Perea, Director Clinical Trials Unit., Director Clinical Trial Unit, Grupo Hospital de Madrid Identifier: NCT01394120    
Other Study ID Numbers: TARGTHPANC 001
2011-001017-13 ( EudraCT Number )
First Posted: July 14, 2011    Key Record Dates
Last Update Posted: March 27, 2012
Last Verified: March 2012
Keywords provided by Sofia Perea, Director Clinical Trials Unit., Grupo Hospital de Madrid:
Pancreas cancer
Targeted Therapy
Additional relevant MeSH terms:
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Carcinoma, Pancreatic Ductal
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Carcinoma, Ductal
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary