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Chemotherapy Selection Based on Therapeutic Targets for Advanced Pancreatic Cancer

NCT01394120 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2012-03-27

No results posted yet for this study

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

Conditions

  • Carcinoma, Pancreatic Ductal

Interventions

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

DRUG

Standard Chemotherapy

Patients treated based on investigator´s criteria: : FOLFIRINOX, FOLFOX, FOLFIRI, Capecitabine-Gemcitabine, Erlotinib-Gemcitabine or Gemcitabine single agent

Sponsors & Collaborators

  • Sofia Perea, Director Clinical Trials Unit.

    lead OTHER

Principal Investigators

  • Manuel Hidalgo, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-12-31
Completion
2013-12-31

Countries

  • Spain

Study Locations

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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 NCT01394120 on ClinicalTrials.gov