Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically or cytologically proven pancreatic carcinoma
Measurable locally advanced or metastatic disease
Patient previously treated with 5-FU as a "radiation sensitizer" and all toxicities must have been resolved
Patients must have received Gemcitabine-based chemotherapy (single agent or combination) as 1st line therapy for advanced or metastatic disease and all toxicities must have been resolved
Patients received the last dose of gemcitabine at least 2 weeks prior to randomization
Confirmed radiographic disease progression (Computed Tomogram (CT) scan or Magnetic Resonance Imaging (MRI) within 4 weeks prior to randomization
Adequate liver and kidney function:
* Total bilirubin inferior than 1.5 Upper Limit of Normal (ULN)
* Creatinine clearance (ClCr) superior than 50 mL / min
* Aspartate Transferase (AST) inferior than 3 ULN if no liver metastasis or AST inferior than 5 ULN if liver metastasis
* Alanine Aminotransferase (ALT) inferior than 3 ULN if no liver metastasis or ALT inferior than 5 ULN if liver metastasis
Adequate hematological function:
* Neutrophils superior or egal to 1.5 x 109/L
* Platelets superior or egal to 100 x 109/L
You may not be if
Peripheral sensory or motor neuropathy \> grade 1
Eastern Cooperative Oncology Group (ECOG) Performance status \> 2
Serious cardiac arrhythmia, diabetes, or serious active infection or other active illness that would preclude study participation in the opinion of the investigator
Pernicious anemia or other megaloblastic anemia with vitamin B12 deficiency
Previous (greater than 5 years) or current malignancies of other origin within the past 5 years
Lack of physical integrity of the upper gastrointestinal tract, clinically significant malabsorption syndrome, or inability to take oral medications
History of known allergy to oxaliplatin or other platinum compounds, to 5-FU, to LV or to any ingredients in the formulations or the containers
Severe renal impairment (ClCr \< 50 mL/min)
Pregnant women or breast-feeding
Patients (male or female) with reproductive potential not implementing accepted and effective method of contraception (the definition of "effective method of contraception" will be based on the investigators' judgment)
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Clareo Health | Randomized Study With Oxaliplatin in 2nd Line Pancreatic Cancer
