Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Instituto do Cancer do Estado de São Paulo
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Pancreatic advanced or metastatic adenocarcinoma histologically confirmed.
Previously treatment with gemcitabine as adjuvant or metastatic disease.
Clinical or radiological evidence of disease progression, determined by physician. Is not mandatory RECIST (Response Evaluation Criteria in Solid Tumors) evaluation to determine the progression of disease before the study inclusion.
Patient with intolerance to gemcitabine, even without disease progression, are also eligible.
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
At least 10 weeks of life expectation.
Adequate organ function defined as:
* Serum AST (aspartate aminotransferase) and ALT (alanine aminotransferase)≤ 2.5 × ULN (upper normal limit)
* Total Bilirubin ≤ 2,0 x ULN
* Absolute neutrophil count ≥ 1,500/ mm3
* Platelets ≥100.000/ mm3
* Hemoglobin ≥ 8,0 g/dl
* Serum Creatinine ≤ 1,5 ULN and clearance of creatinine estimated (Cockcroft- Gault) ≥ 50 ml/min
Signed written informed consent.
You may not be if
Major surgical procedure within 4 weeks of the beginning of the treatment.
History of serious clinical or psychiatric disease.
Symptomatic hypoglycemia at the screening visit.
Target lesion radiotherapy within 4 weeks of the beginning of the treatment.
Treatment with any anti-cancer investigational drug.
Treatment with any IGF-I or IGFR-I
Treatment with metformin within 12 months prior to commencing study treatment
For female patients, current pregnancy and/or lactation
Clareo Health | Treatment of Patients With Advanced Pancreatic Cancer After Gemcitabine Failure.
