Status:
TERMINATED
Chemoradiation With Oxaliplatin and Fluorouracil (5FU) for Locally Advanced Pancreatic Cancer
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Sanofi
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The intention of this trial is to determine the maximum tolerated of the treatment combination and to evaluate its safety and efficacy.
Detailed Description
Previous studies have demonstrated that neoadjuvant chemoradiation can lead to improved survival with a portion of patients proceeding to resection. This trial will incorporate a similar trial structu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00463840
Start Date
June 1 2004
End Date
October 1 2015
Last Update
December 5 2017
Active Locations (2)
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1
Bellevue Hospital
New York, New York, United States, 10016
2
NYU Cancer Institute
New York, New York, United States, 10016