Chemoradiation With Oxaliplatin and Fluorouracil (5FU) for Locally Advanced Pancreatic Cancer
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring Locally advanced pancreatic cancer, oxaliplatin, chemoradiation, 5FU
Eligibility Criteria
Inclusion Criteria:
- Pathologically documented pancreatic adenocarcinoma deemed unresectable due to local involvement of vessels or organs
- Patients with a clear clinical diagnosis of localized pancreatic cancer deemed unresectable, who have undergone at least 2 biopsies which were not diagnostic of adenocarcinoma, may be entered at the discretion of the principal investigator.
- No prior chemotherapy or abdominal radiation therapy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Clinically measurable or evaluable disease.
- Life expectancy of at least 12 weeks.
- Adequate bone marrow reserve, granulocyte count >= 1500/uL, platelet count >= 100,000/uL, hemoglobin >= 9 g/dL.
- Adequate renal function with creatinine =< 1.5 times upper limit of normal (ULN)
- Adequate biliary function with bilirubin < 3.0 g/dL (including patients who have been bypassed or treated with percutaneous drainage), serum glutamic pyruvic transaminase (SGPT) (alanine transaminase) =< 2.5
- Age > 18 years
- Signed informed consent.
- No known allergy to one of the study drugs
- For female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception
- No prior malignancy within last 5 years
- No central nervous system metastases
- No peripheral neuropathy > grade2
- No other serious concomitant illness
Exclusion Criteria:
- Active infection or uncontrolled infection
- Presence of metastatic disease.
- Inadequate organ function as discussed above.
- Pregnancy
- Serious concomitant systemic disorder.
- Use of any investigational agent within a month of treatment
Sites / Locations
- Bellevue Hospital
- NYU Cancer Institute
Arms of the Study
Arm 1
Experimental
Oxaliplatin+ 5FU+ radiation (RT) /surgery /FOLFOX 6
Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal; Combined with : 5FU 200 mg/m^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m^2 Oxaliplatin were tested). Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable. Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle): Day 1 hour 0: Oxaliplatin 85 mg/m^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 IV over 46 hours.