Status:
COMPLETED
Study of Individualized Selection of Chemotherapy in Patients With Advanced Pancreatic Carcinoma According to Therapeutic Targets
Lead Sponsor:
Centro Nacional de Investigaciones Oncologicas CARLOS III
Collaborating Sponsors:
Hospital Universitario de Fuenlabrada
Apices Soluciones S.L.
Conditions:
Advanced Pancreatic Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 groupe...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01454180
Start Date
October 1 2011
End Date
December 1 2014
Last Update
October 9 2015
Active Locations (2)
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1
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, Spain, 28950
2
Hospital Universitario Madrid Sanchinarro
Madrid, Madrid, Spain, 28050