Induction Cetuximab (IM-C225), Gemcitabine, and Oxaliplatin in Pancreatic Cancer Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

September 30, 2005

Primary Completion Date

June 30, 2011

Study Completion Date

June 30, 2011

Conditions
Pancreatic Cancer
Interventions
DRUG

Cetuximab

500 mg/m\^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy.

DRUG

Gemcitabine

"Induction Therapy: 1 gm/m\^2 over 100 minutes every 2 weeks +/-1 day for 4 doses.~Chemotherapy Maintenance: 1 gm/m\^2/week over 100 minutes weekly for 3 weeks then 1 week off."

DRUG

Oxaliplatin

Induction Chemotherapy: 100 mg/m\^2 over 120 minutes every 2 weeks +/-1 day for 4 doses.

DRUG

Capecitabine

Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m\^2 by mouth (PO) twice daily Monday-Friday throughout radiation.

RADIATION

Radiotherapy

Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.

Trial Locations (1)

77030

UT MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER

NCT00338039 - Induction Cetuximab (IM-C225), Gemcitabine, and Oxaliplatin in Pancreatic Cancer Patients | Biotech Hunter | Biotech Hunter