Chemotherapy Selection Based on Therapeutic Targets for Advanced Pancreatic Cancer

NCT01394120 | Unknown Phase 2 DMC

• 2 other identifiers: TARGTHPANC 0012011-001017-13
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Carcinoma, Pancreatic Ductal

Keywords

Pancreas cancer; Targeted Therapy

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  1 year

Study Arms (2)

Tarteted Therapy

EXPERIMENTAL

Drug: Targeted Therapy Tailored Treatment

Standard Chemotherapy

ACTIVE COMPARATOR

Drug: Standard Chemotherapy

Interventions

Targeted Therapy Tailored Treatment DRUG

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

Also known as: Individualized treatment selection based on predictors of response biomarkers

Tarteted Therapy

Standard Chemotherapy DRUG

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

Also known as: Treatment at the investigator's discretion

Standard Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sofia Perea, Director Clinical Trials Unit.: lead

Study Sites (1)

Centro Integral Oncologico Clara Campal

Madrid, 28050, Spain

RECRUITING

MeSH Terms

Conditions

Carcinoma, Pancreatic Ductal; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Manuel Hidalgo, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Clinical Trial Unit

Study Record Dates

• First Submitted: July 5, 2011
• First Posted: July 14, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: March 27, 2012

Record last verified: 2012-03

Locations

ES (1)