Study of Individualized Selection of Chemotherapy in Patients With Advanced Pancreatic Carcinoma According to Therapeutic Targets

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Centro Nacional de Investigaciones Oncologicas CARLOS III.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Hospital Universitario de Fuenlabrada
Apices Soluciones S.L.
Grupo Hospital de Madrid
Information provided by (Responsible Party):
Centro Nacional de Investigaciones Oncologicas CARLOS III
ClinicalTrials.gov Identifier:
NCT01454180
First received: October 11, 2011
Last updated: April 16, 2012
Last verified: April 2012
  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:


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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 de 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 July 29, 2014