Borderline Resectable Pancreatic Cancer: Gemcitabine/Docetaxel and Oxaliplatin Based Chemo/RT

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

September 30, 2008

Primary Completion Date

March 31, 2010

Study Completion Date

April 30, 2010

Conditions
Pancreatic Cancer
Interventions
DRUG

Gemcitabine, Docetaxel, 5FU, Oxaliplatin

Gemcitabine: 1000 mg/m2 IV bolus days 1 and 8, repeated every 21 days x 8cycles Docetaxel: 40 mg/m2 IV bolus days 1 and 8, repeated every 21 days x 8 cycles Gemcitabine/docetaxel will be repeated (based upon initial response) Oxaliplatin: 40 mg/m2 IV on day 1 of each week of radiation 5-FU: 175 mg/m2 continuous infusion on days 1-18 and 29-46 of radiation

BIOLOGICAL

Alpha-interferon

Alpha-interferon: injected subcutaneously on days 1, 3, 5, 8, 10, 12, 15, 17, 29, 31, 33, 36, 38, 40, 43 and 46 during radiation therapy

RADIATION

Abdominal/pelvic radiation therapy

3-D conformal technique. The dose per fraction will be 180cGy, with a total dose of 5040 cGy in 28 fractions. Radiation therapy will be delivered on days 1-18 and days 29-46

PROCEDURE

Pancreaticoduodenectomy

Surgery performed if subject is considered candidate by protocol definition.

Trial Locations (1)

98101

Virginia Mason Medical Center, Seattle

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Benaroya Research Institute

OTHER