Chemoradiation With Oxaliplatin and Fluorouracil (5FU) for Locally Advanced Pancreatic Cancer

• Status: Terminated
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The intention of this trial is to determine the maximum tolerated of the treatment combination and to evaluate its safety and efficacy.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborator: Sanofi
• Treatments: Fluorouracil; Oxaliplatin

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