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

NCT ID: NCT00463840

Last Updated: 2017-12-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2015-10-31

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 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.

Conditions

Pancreatic Cancer

Keywords

Locally advanced pancreatic cancer; oxaliplatin; chemoradiation; 5FU

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Oxaliplatin

Intervention Type: DRUG

5FU

Intervention Type: DRUG

Radiation

Intervention Type: RADIATION

Surgery

Intervention Type: PROCEDURE

FOLFOX 6

Intervention Type: DRUG

this is an established regimen of Oxaliplatin+infusional 5FU/Leucovorin

Interventions

Oxaliplatin

Intervention Type: DRUG

5FU

Intervention Type: DRUG

Radiation

Intervention Type: RADIATION

Surgery

Intervention Type: PROCEDURE

FOLFOX 6

this is an established regimen of Oxaliplatin+infusional 5FU/Leucovorin

Intervention Type: DRUG

Other Intervention Names

Oxaliplatin: Eloxatin; 5-Fluorouracil

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theresa Ryan, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

Bellevue Hospital

New York, New York, United States

NYU Cancer Institute

New York, New York, United States

Countries

United States

Other Identifiers

H11640

Identifier Type: OTHER

Identifier Source: secondary_id

Sanofi-Aventis 0x 03-030

Identifier Type: OTHER

Identifier Source: secondary_id

03-64

Identifier Type: -

Identifier Source: org_study_id