Study of Individualized Selection of Chemotherapy in Patients With Advanced Pancreatic Carcinoma According to Therapeutic Targets - Full Text View

Purpose

The purpose of this study is to determine the proportion of patients alive after 12 months of the beginning of the trial in patients with advanced pancreatic carcinoma individually selected and grouped according to the expression in tumor tissue for therapeutic targets.

Condition	Intervention	Phase
Advanced Pancreatic Carcinoma	Drug: gemcitabine, or gemcitabine and capecitabine, or gemcitabine and erlotinib, or FOLFIRINOX, or FOLFOX, or FOLFIRI. Drug: Gemcitabine, Gemcitabine-Capecitabine, Gemcitabine-Erlotinib, FOLFOXIRI, FOLFOX, FOLFIRI	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Ensayo Fase II de selección Individualizada Del Tratamiento de Quimioterapia en Pacientes Con Carcinoma de páncreas Avanzado en función de la determinación de Dianas terapéuticas en el Tejido Tumoral

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride Capecitabine Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Further study details as provided by Centro Nacional de Investigaciones Oncologicas CARLOS III:

Primary Outcome Measures:

Overall survival [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
The primary endpoint is survival as measured from the start of treatment the patient to the death of the patient according to the Kaplan-Meier. For each treatment arm will determine the overall survival and the survival and actuarial survival at one year

Estimated Enrollment:	60
Study Start Date:	October 2011
Estimated Study Completion Date:	October 2012
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Arm A Control treatment arm will be treated with any of the schemes used in the study according to the discretion of the physician responsible	Drug: gemcitabine, or gemcitabine and capecitabine, or gemcitabine and erlotinib, or FOLFIRINOX, or FOLFOX, or FOLFIRI. Gemcitabine 1000 mg/m2 weekly for 7 weeks, then weekly regimen of 3 weeks every 4 weeks. Gemcitabine - Capecitabine (GEM-CAP):Gemcitabine 1000 mg/m2 weekly for 3 weeks, Capecitabine 830 mg/m2 orally every 12 hours daily for 3 weeks; every 4 weeks. Gemcitabine-Erlotinib: Gemcitabine 1000 mg/m2 weekly for 7 weeks, then weekly regimen of 3 weeks every 4 weeks, Erlotinib 100 mg orally daily FOLFOXIRI: Oxaliplatin 85 mg/m2,irinotecan 180 mg/m2, folinic acid 400 mg/m2, 5'Fluouracilo 400 mg / m2, 5 'fluorouracil 2400 mg/m2 continuous intravenous infusion of 46 hours. Repeated every 14 days. FOLFOX: Oxaliplatin 85 mg/m2, folinic acid 400 mg/m2, 400 mg/m2 5'Fluouracilo, 2400 mg/m2 5'Fluouracilo continuous intravenous infusion of 46 hours. Repeated every 14 days. FOLFIRI: Irinotecan 180 mg/m2, folinic acid 400 mg/m2, 400 mg/m2 5'Fluouracilo intravenous bolus, 5'Fluouracilo 2400 mg / m2 continuous intravenous infusion for 46 hours. Repeated every 14 days.
Experimental: Arm B treatment guided by the therapeutic targets	Drug: Gemcitabine, Gemcitabine-Capecitabine, Gemcitabine-Erlotinib, FOLFOXIRI, FOLFOX, FOLFIRI Gemcitabine 1000 mg/m2 weekly for 7 weeks, then weekly regimen of 3 weeks every 4 weeks. Gemcitabine - Capecitabine (GEM-CAP):Gemcitabine 1000 mg/m2 weekly for 3 weeks, Capecitabine 830 mg/m2 orally every 12 hours daily for 3 weeks; every 4 weeks. Gemcitabine-Erlotinib: Gemcitabine 1000 mg/m2 weekly for 7 weeks, then weekly regimen of 3 weeks every 4 weeks, Erlotinib 100 mg orally daily FOLFOXIRI: Oxaliplatin 85 mg/m2,irinotecan 180 mg/m2, folinic acid 400 mg/m2, 5'Fluouracilo 400 mg / m2, 5 'fluorouracil 2400 mg/m2 continuous intravenous infusion of 46 hours. Repeated every 14 days. FOLFOX: Oxaliplatin 85 mg/m2, folinic acid 400 mg/m2, 400 mg/m2 5'Fluouracilo, 2400 mg/m2 5'Fluouracilo continuous intravenous infusion of 46 hours. Repeated every 14 days. FOLFIRI: Irinotecan 180 mg/m2, folinic acid 400 mg/m2, 400 mg/m2 5'Fluouracilo intravenous bolus, 5'Fluouracilo 2400 mg / m2 continuous intravenous infusion for 46 hours. Repeated every 14 days.

Arms

Assigned Interventions

Active Comparator: Arm A

Control treatment arm will be treated with any of the schemes used in the study according to the discretion of the physician responsible

Drug: gemcitabine, or gemcitabine and capecitabine, or gemcitabine and erlotinib, or FOLFIRINOX, or FOLFOX, or FOLFIRI.

Gemcitabine 1000 mg/m2 weekly for 7 weeks, then weekly regimen of 3 weeks every 4 weeks.
Gemcitabine - Capecitabine (GEM-CAP):Gemcitabine 1000 mg/m2 weekly for 3 weeks, Capecitabine 830 mg/m2 orally every 12 hours daily for 3 weeks; every 4 weeks.
Gemcitabine-Erlotinib: Gemcitabine 1000 mg/m2 weekly for 7 weeks, then weekly regimen of 3 weeks every 4 weeks, Erlotinib 100 mg orally daily
FOLFOXIRI: Oxaliplatin 85 mg/m2,irinotecan 180 mg/m2, folinic acid 400 mg/m2, 5'Fluouracilo 400 mg / m2, 5 'fluorouracil 2400 mg/m2 continuous intravenous infusion of 46 hours. Repeated every 14 days.
FOLFOX: Oxaliplatin 85 mg/m2, folinic acid 400 mg/m2, 400 mg/m2 5'Fluouracilo, 2400 mg/m2 5'Fluouracilo continuous intravenous infusion of 46 hours. Repeated every 14 days.
FOLFIRI: Irinotecan 180 mg/m2, folinic acid 400 mg/m2, 400 mg/m2 5'Fluouracilo intravenous bolus, 5'Fluouracilo 2400 mg / m2 continuous intravenous infusion for 46 hours. Repeated every 14 days.

Experimental: Arm B

treatment guided by the therapeutic targets

Drug: Gemcitabine, Gemcitabine-Capecitabine, Gemcitabine-Erlotinib, FOLFOXIRI, FOLFOX, FOLFIRI

Gemcitabine 1000 mg/m2 weekly for 7 weeks, then weekly regimen of 3 weeks every 4 weeks.
Gemcitabine - Capecitabine (GEM-CAP):Gemcitabine 1000 mg/m2 weekly for 3 weeks, Capecitabine 830 mg/m2 orally every 12 hours daily for 3 weeks; every 4 weeks.
Gemcitabine-Erlotinib: Gemcitabine 1000 mg/m2 weekly for 7 weeks, then weekly regimen of 3 weeks every 4 weeks, Erlotinib 100 mg orally daily
FOLFOXIRI: Oxaliplatin 85 mg/m2,irinotecan 180 mg/m2, folinic acid 400 mg/m2, 5'Fluouracilo 400 mg / m2, 5 'fluorouracil 2400 mg/m2 continuous intravenous infusion of 46 hours. Repeated every 14 days.
FOLFOX: Oxaliplatin 85 mg/m2, folinic acid 400 mg/m2, 400 mg/m2 5'Fluouracilo, 2400 mg/m2 5'Fluouracilo continuous intravenous infusion of 46 hours. Repeated every 14 days.
FOLFIRI: Irinotecan 180 mg/m2, folinic acid 400 mg/m2, 400 mg/m2 5'Fluouracilo intravenous bolus, 5'Fluouracilo 2400 mg / m2 continuous intravenous infusion for 46 hours. Repeated every 14 days.

Detailed Description:

Phase II, open two branches, in which conventional treatment is administered to patients diagnosed with metastatic pancreatic carcinoma. Patients will be randomized (1:1) to a treatment arm or control arm of experimental treatment guided by the therapeutic targets. Patients in the control treatment arm will be treated with any of the schemes used in the study according to the discretion of the physician responsible. Patients will be analyzed as "intention to treat." In the experimental treatment arm (therapeutic targets) and within 15 days will determine the markers of therapeutic targets detailed in the protocol, either from pre-existing tumor sample or a fresh sample obtained by biopsy. Based on the results of this analysis, we prescribe a chemotherapy treatment determined for possible treatments currently used in pancreatic carcinoma, gemcitabine, gemcitabine and capecitabine, gemcitabine and erlotinib, FOLFIRINOX, FOLFOX, FOLFIRI.

Treatment duration is indefinite .

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histological or cytological diagnosis of pancreatic carcinoma.
Patients> 18 years.
Measurable or not measurable disease.
Life expectancy> 3 months at the discretion of the investigator.
Good general condition determined by the ECOG scale (score 0-1)
Candidate for first-line systemic chemotherapy according to standard practice.
Availability of tumor tissue or opportunity for tumor biopsy for the - determination of biomarkers and their correlation with treatment.
Adequate hematologic function: ANC> 1.5 x 103 / L, absolute count of platelets> 100 x 109 / L, normal values of INR and PTT.
Adequate liver function: total serum bilirubin <2 mg / dL, ALT and AST <3 times the upper limit established by the laboratory (LSR) or <5 LSR in patients with liver metastases.
Adequate renal function: serum creatinine <1.5 LSR.

Exclusion Criteria:

Patients who have received prior chemotherapy for advanced pancreatic carcinoma. Will not result excluding patients who had previously received adjuvant treatment with gemcitabine or fluoropyrimidines. Also not will be excluded patients who had previously received preoperative neoadjuvant treatment for localized disease with chemotherapy and / or radiotherapy.
Patients for whom is contraindicated the administration of either drug used in first-line treatment for pancreatic cancer: Gemcitabine, 5'Fluouracilo, Leucovorin, Capecitabine, Oxaliplatin, Irinotecan, Erlotinib.
Pregnant or breastfeeding women

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01454180

Locations

Spain
Hospital Universitario de Fuenlabrada	Recruiting
Fuenlabrada, Madrid, Spain, 28950
Contact: Antonio López, Biologist (+34)91 600 60 28 ext 6028 alopeza@cnio.es
Contact: Laura Ledesma, Nurse, Data Manager (+34)91 600 65 84 ext 6484 lledesma@ext.cnio.es
Principal Investigator: Manuel Hidalgo, M.D., PhD
Sub-Investigator: Carlos Gómez, M.D., Ph.D
Sub-Investigator: Elena Garralda, M.D.
Hospital Universitario Madrid Sanchinarro	Recruiting
Madrid, Spain, 28050
Contact: Sofía Perea, M.D., Ph. D (+34)91 756 79 84 sofiaperea@hspitaldemadrid.com
Contact: Gemma Sánchez, Study Coordinator +34)91 756 79 84 gsanchez@fundacionhospitaldemadrid.com
Principal Investigator: Jesús Rodríguez, M.D., Ph.D
Sub-Investigator: Manuel Hidalgo, MD, PhD
Sub-Investigator: Antonio Cubillo, MD, Ph D

Sponsors and Collaborators

Centro Nacional de Investigaciones Oncologicas CARLOS III

Hospital Universitario Fuenlabrada

Apices Soluciones S.L.

Grupo Hospital de Madrid

Investigators

Study Director:

Manuel Hidalgo, M.D.,PhD

CNIO

More Information

No publications provided

Responsible Party:	Centro Nacional de Investigaciones Oncologicas CARLOS III
ClinicalTrials.gov Identifier:	NCT01454180 History of Changes
Other Study ID Numbers:	CNIO-GI-01-2011
Study First Received:	October 11, 2011
Last Updated:	April 16, 2012
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Centro Nacional de Investigaciones Oncologicas CARLOS III:

Therapeutic targets in Pancreas

Additional relevant MeSH terms:

Carcinoma
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Capecitabine
Fluorouracil
Erlotinib

Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on June 17, 2013