This trial is active, not recruiting.

Condition pancreatic cancer
Treatments oxaliplatin, 5fu, radiation, surgery, folfox 6
Phase phase 1/phase 2
Sponsor New York University School of Medicine
Collaborator Sanofi
Start date June 2004
End date July 2010
Trial size 24 participants
Trial identifier NCT00463840, 03-64, H11640, Sanofi-Aventis 0x 03-030


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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.
oxaliplatin Oxaliplatin: Eloxatin
5fu 5-Fluorouracil
folfox 6
this is an established regimen of Oxaliplatin+infusional 5FU/Leucovorin

Primary Outcomes

Resectability After Chemoradiation
time frame: 7.5 weeks

Secondary Outcomes

Median Overall Survival
time frame: up to 10 years since the start of the study

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase I/II Study of Chemoradiation With Oxaliplatin and 5FU for Locally Advanced Pancreatic Cancer
Principal investigator Theresa Ryan, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by New York University School of Medicine.