Chemotherapy Selection Based on Therapeutic Targets for Advanced Pancreatic Cancer

Sponsor

Sofia Perea, Director Clinical Trials Unit. (Other)

Overall Status

Unknown status

CT.gov ID

NCT01394120

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Aug 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2012

Anticipated Study Completion Date :

Dec 1, 2013

Arms and Interventions

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 Names: 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 Names: Treatment at the investigator's discretion

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 Names:

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 Names:

Treatment at the investigator's discretion

Outcome Measures

Primary Outcome Measures

Overall Survival [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Centro Integral Oncologico Clara Campal	Madrid		Spain	28050

Sponsors and Collaborators

Sofia Perea, Director Clinical Trials Unit.

Investigators

Principal Investigator: Manuel Hidalgo, MD,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sofia Perea, Director Clinical Trials Unit., Director Clinical Trial Unit, Grupo Hospital de Madrid

ClinicalTrials.gov Identifier:

NCT01394120

Other Study ID Numbers:

TARGTHPANC 001
2011-001017-13

First Posted:

Jul 14, 2011

Last Update Posted:

Mar 27, 2012

Last Verified:

Mar 1, 2012

Keywords provided by Sofia Perea, Director Clinical Trials Unit., Director Clinical Trial Unit, Grupo Hospital de Madrid

Pancreas cancer

Targeted Therapy

Additional relevant MeSH terms:

Carcinoma, Pancreatic Ductal

Study Results

No Results Posted as of Mar 27, 2012