BrUOG 278: FOLFOX-A For Pancreatic Cancer A Brown University Oncology Research Group Study

Inclusion Criteria

• •Pathologically confirmed pancreatic ductal adenocarcinoma.
• •Metastatic or locally advanced disease.
• •No prior treatment for pancreatic cancer
• •Radiographically measurable disease.
• •No major surgery within 4 weeks of the start of study treatment. Patients must have recovered from the side effects of any major surgery at the start of study treatment. Laparoscopy and central venous catheter placement are not considered major surgery.
• •Patients with serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive FOLFOX-A
• •Preexisting neuropathy \> grade 1.
• •No prior invasive malignancy within the prior two years. However, patients with an early stage malignancy that is not expected to require treatment in the next 2 years (such as early stage, resected breast cancer or asymptomatic prostate cancer) are eligible.
• •ECOG performance status 0 or 1.
• •Age ≥ 18 years of age.
• •Not pregnant and not nursing. Women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to beginning of treatment.
• •Required Initial Laboratory Values:
• •* Neutrophils ≥ 1,500/μl
• •* Platelet count ≥ 100,000/μl
• •* Creatinine ≤ 1.5 mg/dL -or- creatinine clearance ≥ 60 mL/min
• •* Total bilirubin ≤ 1.5 x ULN
• •* AST (SGOT) \& ALT (SGPT) ≤ 3.0 x ULN