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

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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 grouped according to the expression in tumor tissue for therapeutic targets.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centro Nacional de Investigaciones Oncologicas CARLOS III
• Collaborators: Apices Soluciones S.L.; Grupo Hospital de Madrid; Hospital Universitario de Fuenlabrada
• Treatments: Capecitabine; Erlotinib Hydrochloride; Fluorouracil; Folfirinox; Gemcitabine; Leucovorin; Oxaliplatin

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