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

Stopped early · Phase 1/Phase 2

Conditions studied: Pancreatic Cancer

In brief

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

Key facts

Study ID

NCT00463840

Run by

NYU Langone Health

People needed

24

Starts

2004-06-01

Expected to finish

2015-10-01

Last updated by the study team

2017-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Bellevue Hospital — New York, New York, United States
• NYU Cancer Institute — New York, New York, United States

Full record on ClinicalTrials.gov

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