- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01454180
Study of Individualized Selection of Chemotherapy in Patients With Advanced Pancreatic Carcinoma According to Therapeutic Targets
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
Study Overview
Status
Conditions
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 .
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Madrid, Spain, 28050
- Hospital Universitario Madrid Sanchinarro
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Madrid
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Fuenlabrada, Madrid, Spain, 28950
- Hospital Universitario de Fuenlabrada
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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
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EXPERIMENTAL: Arm B
treatment guided by the therapeutic targets
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 12 months
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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
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12 months
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Collaborators and Investigators
Investigators
- Study Director: Manuel Hidalgo, M.D.,PhD, CNIO
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Carcinoma
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Micronutrients
- Protein Kinase Inhibitors
- Vitamins
- Antidotes
- Vitamin B Complex
- Gemcitabine
- Erlotinib Hydrochloride
- Fluorouracil
- Capecitabine
- Oxaliplatin
- Leucovorin
- Folfirinox
Other Study ID Numbers
- CNIO-GI-01-2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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