Conditions: Pancreatic Cancer
Keywords: Locally advanced pancreatic cancer oxaliplatin chemoradiation 5FU
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 24
Healthy volunteers: no

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.

Arms:
arm 1: 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.

Interventions: intervention 1: Oxaliplatin intervention 2: 5FU intervention 3: Radiation intervention 4: Surgery intervention 5: FOLFOX 6
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: this is an established regimen of Oxaliplatin+infusional 5FU/Leucovorin

Protocol document: