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

NYU Langone Health

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Pancreatic Cancer

Treatments: Drug: FOLFOX 6; Drug: Oxaliplatin; Radiation: Radiation; Procedure: Surgery; Drug: 5FU

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00463840

Sanofi-Aventis 0x 03-030 (Other Identifier)

H11640 (Other Identifier)

03-64

Details and patient eligibility

About

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

Full 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 structure using newer agents in patients who present with locally advanced unresectable pancreatic cancer. Specifically oxaliplatin will be used owing to its greater activity in comparison to cisplatin and favorable therapeutic index in combination with radiation compared to gemcitabine.

In summary, the primary outcome measure of the phase I portion of the trial is to determine the maximum tolerated dose of this combination. Following the determination of this dose, the phase II portion of the trial will characterize the toxicity of this regimen as well as evaluate for long-term efficacy.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Oxaliplatin+ 5FU+ radiation (RT) /surgery /FOLFOX 6

Experimental group

Description:

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.

Treatment:

Radiation: Radiation

Drug: 5FU

Drug: FOLFOX 6

Procedure: Surgery

Drug: Oxaliplatin