Chemotherapy Selection Based on Therapeutic Targets for Advanced Pancreatic Cancer

Carcinoma, Pancreatic Ductal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01394120
• Other study ID #: TARGTHPANC 001
• Secondary ID: 2011-001017-13
• Status: Recruiting
• Phase: Phase 2
• First received: July 5, 2011
• Last updated: March 24, 2012
• Start date: August 2011
• Est. completion date: December 2013

Study information

• Verified date: March 2012
• Source: Grupo Hospital de Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Pancreatic Ductal
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Spain	Centro Integral Oncologico Clara Campal	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Sofia Perea, Director Clinical Trials Unit.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		1 year	No